Trial Outcomes & Findings for Diabetes Data-Assisted Remission Trial (DDART) (NCT NCT04663061)
NCT ID: NCT04663061
Last Updated: 2026-04-03
Results Overview
Change in weight from baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
baseline through 12 months
Results posted on
2026-04-03
Participant Flow
Participant milestones
| Measure |
High Intensity Medical Weight Loss (HIWL)
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
20
|
|
Overall Study
COMPLETED
|
14
|
8
|
16
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
4
|
Reasons for withdrawal
| Measure |
High Intensity Medical Weight Loss (HIWL)
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
Diabetes Data-Assisted Remission Trial (DDART)
Baseline characteristics by cohort
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=22 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=22 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=20 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53.41 years
STANDARD_DEVIATION 10.46 • n=5 Participants
|
55.09 years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
63.60 years
STANDARD_DEVIATION 10.44 • n=10 Participants
|
57.17 years
STANDARD_DEVIATION 11.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=10 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=10 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
21 Participants
n=5 Participants
|
18 Participants
n=10 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=10 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=10 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline through 12 monthsPopulation: HIWL Arm: 8 missing weight measurement at month 12. DSME Arm: 15 missing weight measurement at month 12. HIWL/CGM Arm: 4 missing weight measurement at month 12.
Change in weight from baseline
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=14 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=7 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=16 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Change in Body Weight
|
-10.73 kg
Standard Deviation 7.10
|
-6.15 kg
Standard Deviation 7.99
|
-9.09 kg
Standard Deviation 6.59
|
SECONDARY outcome
Timeframe: baseline through 12 monthsPopulation: HIWL Arm: 8 missing month 12 labs. DSME Arm: 15 missing month 12 labs. HIWL/CGM: 1 missing baseline labs, 5 missing month 12 labs.
Change in hemoglobin A1c
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=14 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=7 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=14 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Change in Hemoglobin A1c
|
-1.00 percentage of change in hemoglobin A1c
Standard Deviation 0.94
|
-0.67 percentage of change in hemoglobin A1c
Standard Deviation 0.96
|
-0.65 percentage of change in hemoglobin A1c
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: HIWL Arm: 8 missing month 12 labs. DSM Arm: 15 missing month 12 labs. HIWL/CGM Arm: 5 missing month 12 labs. Participants who are missing month 12 labs were lost to follow up, withdrew consent, or unwilling to perform labs at final study visit.
Number of participants achieving A1c \<6.5% and no anti-diabetes medications
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=14 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=7 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=15 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Number of Subjects in Diabetes Remission
|
10 Participants
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: baseline and month 12Population: Sample size reflects participants with at least one valid CGM reading contributing to the specified outcome. For baseline, data was missing from 2 participants in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 7 (5 without sufficient data, 1 was lost to follow up, and 1 was deceased). DSME Arm: 6 (5 without sufficient data; 1 participant missing due to withdrawing). HIWL/CGM Arm: 6 without sufficient data
Average time spent at an average glucose of 100 mg/dL or lower collected by FreeStyle Libre.
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=20 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=20 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=19 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Continuous Glucose Monitoring (CGM) Time in Range
month 12
|
20.9 % of time
Standard Deviation 29.3
|
17.4 % of time
Standard Deviation 25.0
|
23.7 % of time
Standard Deviation 27.2
|
|
Continuous Glucose Monitoring (CGM) Time in Range
baseline
|
11.0 % of time
Standard Deviation 13.1
|
9.4 % of time
Standard Deviation 11.7
|
14.4 % of time
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: baseline through 12 monthsPopulation: Sample size reflects participants with at least one valid CGM reading contributing to the specified outcome. For baseline, data was missing from 2 participants in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 7 (5 without sufficient data, 1 was lost to follow up, and 1 was deceased). DSME Arm: 6 (5 without sufficient data; 1 participant missing due to withdrawing). HIWL/CGM Arm: 6 without sufficient data
Average time spent at a post-meal glucose level of 110 mg/dL or lower collected by FreeStyle Libre.
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=20 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=20 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=19 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Continuous Glucose Monitoring Time in Range--Post-meal Glucose
12 months
|
31.7 % of time
Standard Deviation 32.8
|
28.5 % of time
Standard Deviation 31.1
|
33.4 % of time
Standard Deviation 26.7
|
|
Continuous Glucose Monitoring Time in Range--Post-meal Glucose
Baseline
|
21.6 % of time
Standard Deviation 20.2
|
17.4 % of time
Standard Deviation 18.7
|
25.5 % of time
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: baseline through 12 monthsPopulation: Sample size reflects participants with at least one valid CGM reading contributing to the specified outcome. For baseline, data was missing from 2 participants in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 7 (5 without sufficient data, 1 was lost to follow up, and 1 was deceased). DSME Arm: 10 (9 without sufficient data; 1 participant missing due to withdrawing). HIWL/CGM Arm: 6 without sufficient data
Average time spent in normal fasting glucose between 72-85 mg/dL collected by FreeStyle Libre.
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=20 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=20 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=19 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Continuous Glucose Monitor Time in Range--Fasting Glucose
12 months
|
8.3 % of time
Standard Deviation 19.1
|
1.6 % of time
Standard Deviation 4.9
|
6.9 % of time
Standard Deviation 11.8
|
|
Continuous Glucose Monitor Time in Range--Fasting Glucose
Baseline
|
1.7 % of time
Standard Deviation 5.0
|
1.1 % of time
Standard Deviation 2.9
|
5.9 % of time
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: baseline and month 12Population: Baseline data was missing from 1 participant in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 4 not analyzed (3 participants missing due to withdrawing, and 1 was deceased). DSME Arm: 3 not analyzed (3 participants missing due to withdrawing). HIWL/CGM Arm: 1 participant due to withdrawing
Number of episodes hypoglycemia (\<70 mg/dL) episodes collected by FreeStyle Libre.
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=21 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=20 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=19 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Continuous Glucose Monitor - Episodes of Hypoglycemia
baseline
|
0.38 number of hypoglycemia episodes/person
Standard Deviation 1.12
|
0.05 number of hypoglycemia episodes/person
Standard Deviation 0.22
|
0.37 number of hypoglycemia episodes/person
Standard Deviation 0.50
|
|
Continuous Glucose Monitor - Episodes of Hypoglycemia
month 12
|
4.06 number of hypoglycemia episodes/person
Standard Deviation 16.71
|
0.21 number of hypoglycemia episodes/person
Standard Deviation 0.92
|
2.68 number of hypoglycemia episodes/person
Standard Deviation 6.92
|
SECONDARY outcome
Timeframe: baseline and month 12Population: Baseline data was missing from 1 participant in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 4 not analyzed (3 participants missing due to withdrawing, and 1 was deceased). DSME Arm: 3 not analyzed (3 participants missing due to withdrawing). HIWL/CGM Arm: 1 participant due to withdrawing
Coefficient of variance collected by FreeStyle Libre.
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=21 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=20 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=19 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Continuous Glucose Monitor - Glucose Variability
baseline
|
21.72 percentage of coefficient of variation
Standard Deviation 5.99
|
21.77 percentage of coefficient of variation
Standard Deviation 3.89
|
20.97 percentage of coefficient of variation
Standard Deviation 4.18
|
|
Continuous Glucose Monitor - Glucose Variability
month 12
|
20.31 percentage of coefficient of variation
Standard Deviation 4.92
|
19.01 percentage of coefficient of variation
Standard Deviation 7.13
|
21.60 percentage of coefficient of variation
Standard Deviation 5.79
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: Baseline data was missing from 1 participant in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 4 not analyzed (3 participants missing due to withdrawing, and 1 was deceased). DSME Arm: 3 not analyzed (3 participants missing due to withdrawing). HIWL/CGM Arm: 1 participant due to withdrawing
Average glucose (mg/dL) collected by FreeStyle Libre.
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=21 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=20 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=19 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Continuous Glucose Monitoring - Average Glucose
baseline
|
139.29 mg/dL
Standard Deviation 18.78
|
163.53 mg/dL
Standard Deviation 56.22
|
139.16 mg/dL
Standard Deviation 29.00
|
|
Continuous Glucose Monitoring - Average Glucose
month 12
|
135.12 mg/dL
Standard Deviation 31.75
|
141.23 mg/dL
Standard Deviation 49.50
|
125.13 mg/dL
Standard Deviation 24.24
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: Outcome data for this variable cannot be reported because the data are no longer available. The relevant outcome measures were collected using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). After completion of the study, the specific version of ASA24 used for data collection was sunset and decommissioned. The data could not be transferred to the subsequent version of the ASA24 platform, and the original dataset is no longer accessible.
kilocalories averaged across 3 days
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: Outcome data for this variable cannot be reported because the data are no longer available. The relevant outcome measures were collected using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). After completion of the study, the specific version of ASA24 used for data collection was sunset and decommissioned. The data could not be transferred to the subsequent version of the ASA24 platform, and the original dataset is no longer accessible.
%Carbohydrate/Fat/Protein; averaged across 3 days
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: Outcome data for this variable cannot be reported because the data are no longer available. The relevant outcome measures were collected using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). After completion of the study, the specific version of ASA24 used for data collection was sunset and decommissioned. The data could not be transferred to the subsequent version of the ASA24 platform, and the original dataset is no longer accessible.
averaged across 3 days
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: Outcome data for this variable cannot be reported because the data are no longer available. The relevant outcome measures were collected using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). After completion of the study, the specific version of ASA24 used for data collection was sunset and decommissioned. The data could not be transferred to the subsequent version of the ASA24 platform, and the original dataset is no longer accessible.
A validated summary measure of dietary quality, rated on a 100-point scale with a higher score denoting better diet quality
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: HIWL Arm: Missing 1 participant at baseline, 19 at month 3, 18 at month 6, 19 at month 12. DSME Arm: Missing 1 participant at baseline, 18 at month 3, 17 at month 6, 22 at month 12. HIWL/CGM Arm: Missing 12 participants at month 3, 10 at month 6, 17 at month 12. Participants were missing due to failure to return equipment, refusal to use pedometer or lost to follow up.
Collected by pedometer over 7 days during each period. At the end of the 7th day, participants will record the final step count, and return the pedometer to the study team via a pre-stamped mail envelope.
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=22 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=22 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=20 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Daily Step Counts
baseline
|
2986.52 step count
Standard Deviation 2922.91
|
2488.95 step count
Standard Deviation 1903.58
|
4440.5 step count
Standard Deviation 3489.07
|
|
Daily Step Counts
month 3
|
4289.33 step count
Standard Deviation 3714.70
|
5792.25 step count
Standard Deviation 5051.28
|
6324.63 step count
Standard Deviation 4453.78
|
|
Daily Step Counts
month 6
|
2787 step count
Standard Deviation 1131.57
|
4585.8 step count
Standard Deviation 4234.00
|
6530.2 step count
Standard Deviation 5778.55
|
|
Daily Step Counts
month 12
|
1900.33 step count
Standard Deviation 1004.68
|
—
|
5868.00 step count
Standard Deviation 6799.07
|
SECONDARY outcome
Timeframe: from baseline to month 12Population: 8 participants in HIWL arm, 15 participants in DSME arm and 4 participants in HIWL/CGM arm were lost to follow up, dropped from study or missing data at baseline visit.
The EuroQol's EQ-5D-5L will be used to measure quality of life. This instrument takes responses to five questions on mobility, self-care, ability to perform usual activities, pain, and anxiety/depression to produce a validated quality score. Total score range is 5-25 with a lower score indicating a better quality of life.
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=14 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=7 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=16 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Change in Quality of Life
|
0.01 score on a scale
Standard Deviation 0.23
|
0.0 score on a scale
Standard Deviation 0.40
|
0.03 score on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: from baseline to month 12Population: 8 participants in HIWL arm, 16 participants in DSME arm and 4 participants in HIWL/CGM arm were lost to follow up, dropped from study or missing data at baseline visit.
The EuroQol's EQ-5D-5L visual analog scale will be used to measure participants perceived health. On a scale of 0-100 participants will rate their health. 0 means the worst health you can imagine. 100 means the best health you can imagine.
Outcome measures
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=14 Participants
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=6 Participants
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=16 Participants
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Change in Perceived Health Rating
|
2.36 score on a scale
Standard Deviation 18.45
|
-11.83 score on a scale
Standard Deviation 22.09
|
7.19 score on a scale
Standard Deviation 13.85
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: This measure was not collected as it was considered redundant with the other assessment of physical activity and was not part of the IRB approved measures.
A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of walking for exercise. Outcome is average total minutes/week.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: This measure was not collected as it was considered redundant with the other assessment of physical activity and was not part of the IRB approved measures.
A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of sitting time. Outcome is average total minutes/week.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, 3 months, 6 months, and 12 monthsPopulation: This measure was not collected as it was considered redundant with the other assessment of physical activity and was not part of the IRB approved measures.
A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of moderate and vigorous physical activity. Outcome is average total minutes/week.
Outcome measures
Outcome data not reported
Adverse Events
High Intensity Medical Weight Loss (HIWL)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 1 deaths
Diabetes Self-management Education (DSME)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=22 participants at risk
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=22 participants at risk
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=20 participants at risk
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
0.00%
0/22 • baseline through month 12
|
0.00%
0/20 • baseline through month 12
|
Other adverse events
| Measure |
High Intensity Medical Weight Loss (HIWL)
n=22 participants at risk
Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
|
Diabetes Self-management Education (DSME)
n=22 participants at risk
The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings.
The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process.
Diabetes education: Participants will receive standard of care diabetes education
|
High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM)
n=20 participants at risk
Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways.
Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time
|
|---|---|---|---|
|
General disorders
surgery, no hospitalization
|
9.1%
2/22 • Number of events 2 • baseline through month 12
|
0.00%
0/22 • baseline through month 12
|
10.0%
2/20 • Number of events 2 • baseline through month 12
|
|
Injury, poisoning and procedural complications
broken bone
|
0.00%
0/22 • baseline through month 12
|
0.00%
0/22 • baseline through month 12
|
5.0%
1/20 • Number of events 1 • baseline through month 12
|
|
General disorders
shortness of breath
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
0.00%
0/22 • baseline through month 12
|
0.00%
0/20 • baseline through month 12
|
|
General disorders
fatigue
|
18.2%
4/22 • Number of events 4 • baseline through month 12
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
0.00%
0/20 • baseline through month 12
|
|
General disorders
dizziness/balance problem
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
0.00%
0/20 • baseline through month 12
|
|
General disorders
leg weakness
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
0.00%
0/22 • baseline through month 12
|
0.00%
0/20 • baseline through month 12
|
|
General disorders
nausea
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
0.00%
0/22 • baseline through month 12
|
0.00%
0/20 • baseline through month 12
|
|
General disorders
muscle or joint pain
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
0.00%
0/22 • baseline through month 12
|
0.00%
0/20 • baseline through month 12
|
|
Infections and infestations
Covid-19
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
0.00%
0/22 • baseline through month 12
|
0.00%
0/20 • baseline through month 12
|
|
General disorders
abscess
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
0.00%
0/22 • baseline through month 12
|
0.00%
0/20 • baseline through month 12
|
|
General disorders
constipation
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
4.5%
1/22 • Number of events 1 • baseline through month 12
|
10.0%
2/20 • Number of events 3 • baseline through month 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place