Trial Outcomes & Findings for AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy (NCT NCT05370612)
NCT ID: NCT05370612
Last Updated: 2026-03-31
Results Overview
Completion of the study within the 24-month timeframe, including recruitment, randomization, retention, and completion of 36 out of 40 subjects will be a measure of how feasible the intervention is.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
up to 24 months
Results posted on
2026-03-31
Participant Flow
Participant milestones
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy
Baseline characteristics by cohort
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
20-29 years
|
2 participants
n=4 Participants
|
2 participants
n=28 Participants
|
4 participants
n=10 Participants
|
|
Age, Customized
30-39 years
|
5 participants
n=4 Participants
|
5 participants
n=28 Participants
|
10 participants
n=10 Participants
|
|
Age, Customized
40-49 years
|
1 participants
n=4 Participants
|
1 participants
n=28 Participants
|
2 participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=4 Participants
|
8 Participants
n=28 Participants
|
16 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=4 Participants
|
4 Participants
n=28 Participants
|
5 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=4 Participants
|
4 Participants
n=28 Participants
|
11 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=4 Participants
|
6 Participants
n=28 Participants
|
11 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=4 Participants
|
8 Participants
n=28 Participants
|
16 Participants
n=10 Participants
|
|
Private insurance status
Has private insurance
|
7 Participants
n=4 Participants
|
7 Participants
n=28 Participants
|
14 Participants
n=10 Participants
|
|
Private insurance status
Does not have private insurance
|
1 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
|
Most recent A1C
|
6.5 percent glycated hemoglobin
STANDARD_DEVIATION 1.6 • n=4 Participants
|
6.4 percent glycated hemoglobin
STANDARD_DEVIATION 1.0 • n=28 Participants
|
6.43 percent glycated hemoglobin
STANDARD_DEVIATION 1.30 • n=10 Participants
|
|
Pre-existing Hypertension
|
2 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
3 Participants
n=10 Participants
|
|
Number of living children
|
1 number of children
n=4 Participants
|
1 number of children
n=28 Participants
|
1 number of children
n=10 Participants
|
|
Pre-pregnancy Insulin Use
|
2 Participants
n=4 Participants
|
3 Participants
n=28 Participants
|
5 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: up to 24 monthsCompletion of the study within the 24-month timeframe, including recruitment, randomization, retention, and completion of 36 out of 40 subjects will be a measure of how feasible the intervention is.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Feasibility: Number of Participants Who Complete the Study Within 24 Month Time Period
|
8 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 weeks on study, and postpartum (up to 26 weeks on study)Individualized postpartum interviews and qualitative surveys administered at each time point will be used to gather information about participants thoughts and experiences in both arms of the trial about their ability to manage diabetes in pregnancy. Interviews will be analyzed for theme and content. Higher numbers indicate higher satisfaction with diabetes management.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
Postpartum: Satisfied with pregnancy burden managing diabetes
|
3.6 number of times mentioned
Standard Deviation 1.1
|
2.8 number of times mentioned
Standard Deviation 1.3
|
|
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
Baseline : Satisfied with pregnancy burden managing diabetes
|
3.5 number of times mentioned
Standard Deviation 1.6
|
2.5 number of times mentioned
Standard Deviation 1.2
|
|
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
12 weeks: Comfortable managing diabetes before pregnancy
|
2.3 number of times mentioned
Standard Deviation 1.0
|
2.8 number of times mentioned
Standard Deviation 1.3
|
|
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
12 weeks: Comfortable managing diabetes during and post pregnancy
|
2.0 number of times mentioned
Standard Deviation 0.6
|
2.0 number of times mentioned
Standard Deviation 0.7
|
|
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
12 weeks: Satisfied with pregnancy burden managing diabetes
|
3.7 number of times mentioned
Standard Deviation 0.8
|
2.2 number of times mentioned
Standard Deviation 1.1
|
|
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
Postpartum: Comfortable managing diabetes before pregnancy
|
2.3 number of times mentioned
Standard Deviation 0.8
|
3.2 number of times mentioned
Standard Deviation 1.7
|
|
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
Postpartum: Comfortable managing diabetes during and post pregnancy
|
2.0 number of times mentioned
Standard Deviation 0.8
|
2.7 number of times mentioned
Standard Deviation 0.8
|
|
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
Baseline : Comfortable managing diabetes before pregnancy
|
2.5 number of times mentioned
Standard Deviation 0.9
|
2.8 number of times mentioned
Standard Deviation 1.6
|
|
Change in Qualitative Survey Answers to Assess Participant Thoughts and Experiences With Diabetes Management
Baseline : Comfortable managing diabetes during and post pregnancy
|
2.6 number of times mentioned
Standard Deviation 1.2
|
2.1 number of times mentioned
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Baseline, 26 weeksThe primary endpoint is the total time within range (blood glucose level 70-140 mg/dL). All CGM data will be extracted from the Dexcom server for analysis. This measure is used to determine if time in range (TIR) is a suitable clinical endpoint for a larger trial. TIR for both arms will be determined and 95% confidence intervals around the difference in means calculated. TIR will be considered suitable if the upper 95% confidence interval for the difference in means is greater than 5 units in favor of CGM.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Percentage of Time Where Blood Glucose is Between 70-140 Milligrams Per Deciliter (mg/dL) - Time in Range
Baseline
|
64 percentage of time in range
Interval 39.0 to 89.0
|
65 percentage of time in range
Interval 36.0 to 94.0
|
|
Percentage of Time Where Blood Glucose is Between 70-140 Milligrams Per Deciliter (mg/dL) - Time in Range
26 weeks
|
72 percentage of time in range
Interval 47.0 to 97.0
|
55 percentage of time in range
Interval 22.0 to 89.0
|
SECONDARY outcome
Timeframe: approximately 20 weeks on study (at time of delivery)Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Number of Participants With Cesarean Delivery
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: baseline (approximately 20 weeks gestation), up to 12 weeks on study (up to 32 weeks gestation)Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Change in Hemoglobin A1c (Percentage) From Initiation to Third Trimester
|
-0.2 percentage of A1c
Interval -0.6 to 0.3
|
0.0 percentage of A1c
Interval -0.5 to 0.5
|
SECONDARY outcome
Timeframe: up to 26 weeksHyperglycemic range is considered greater than 140 mg/dL. A very high hyperglycemic range is \>250mg/dL.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Percentage of Time Spent in Hyperglycemic Range
Very high (>250)
|
11 percentage of time
Interval 0.0 to 31.0
|
22 percentage of time
Interval 0.0 to 48.0
|
|
Percentage of Time Spent in Hyperglycemic Range
High (140-249)
|
16 percentage of time
Interval 2.0 to 29.0
|
22 percentage of time
Interval 3.0 to 42.0
|
SECONDARY outcome
Timeframe: 26 weeksHypoglycemic range is considered less than 70 mg/dL. Low is 55-70, very low is \<54.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Percentage of Time Spent in Hypoglycemic Range
Low (55-70)
|
1 percentage of time
Interval 0.0 to 2.0
|
2 percentage of time
Interval 0.0 to 4.0
|
|
Percentage of Time Spent in Hypoglycemic Range
Very low (<54)
|
0 percentage of time
Interval 0.0 to 1.0
|
1 percentage of time
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: up to approximately 20 weeks on studyGestational hypertension is defined as systolic blood pressure 140 mm Hg or diastolic blood pressure 90 mg Hg on two occasions at least 4 hours apart.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Rates of Gestational Hypertension
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to approximately 20 weeks on studyGestational hypertension plus either new-onset proteinuria \[300 mg/24 hours, protein:creatinine 0.3 mg/dL\], thrombocytopenia \[platelet count\<100,000/uL\], elevated Aspartate transaminase or alanine transaminase \[\>2 upper limit of normal\], renal insufficiency \[serum creatinine\>1.1 mg/dL or an unexplained doubling of creatinine\], pulmonary edema, or cerebral or visual symptoms.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Rates of Preeclampsia
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to approximately 20 weeks on studyOutcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Rates of Polyhydramnios
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 26 weeksOutcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Incidence of Neonatal Hypoglycemia
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 26 weeksActual birthweight greater than 95 percent by Fenton growth curve for newborns
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Rates of Fetal Macrosomia
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 26 weeksOutcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Rates of NICU Admission
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to approximately 17 weeks on study (less than 37 weeks gestation)Preterm delivery is considered less than 37 weeks.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Rates of Spontaneous Preterm Delivery
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)Population: Some participants did not answer surveys at all time points.
Satisfaction and Quality of Life survey will be administered and answers will be compared between groups. Survey questions include answers on a 5-point Likert scale. Scores range from 15-75, where higher scores indicate lower satisfaction and quality of life, and lower scores indicate higher satisfaction and quality of life.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Satisfaction and Quality of Life Survey Scores (5-point Likert Scale)
28-32 weeks gestation
|
27.6 score on a scale
Interval 18.1 to 37.1
|
35.2 score on a scale
Interval 24.8 to 45.5
|
|
Satisfaction and Quality of Life Survey Scores (5-point Likert Scale)
Baseline
|
35.2 score on a scale
Interval 26.9 to 43.6
|
34.8 score on a scale
Interval 25.2 to 44.5
|
|
Satisfaction and Quality of Life Survey Scores (5-point Likert Scale)
2-4 weeks postpartum
|
29.6 score on a scale
Interval 21.0 to 38.2
|
38.3 score on a scale
Interval 28.3 to 48.3
|
SECONDARY outcome
Timeframe: 2-4 weeks postpartum (up to 26 weeks on study)The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Mood
|
4 Number of times comment made
|
0 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Phone App satisfaction
|
6 Number of times comment made
|
2 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Stress
|
6 Number of times comment made
|
9 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Feelings of guilt
|
1 Number of times comment made
|
1 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Impact of diabetes on pregnancy and concern
|
12 Number of times comment made
|
10 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Learning
|
1 Number of times comment made
|
1 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
CGM Placement
|
7 Number of times comment made
|
0 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Concern for fetus
|
1 Number of times comment made
|
3 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Feeling like a burden on the healthcare system
|
3 Number of times comment made
|
0 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Feeling method is convenient
|
6 Number of times comment made
|
2 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Cost effectiveness
|
3 Number of times comment made
|
2 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Customer service ease with device
|
1 Number of times comment made
|
0 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Perception of device accuracy
|
7 Number of times comment made
|
2 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Dissatisfaction with finger sticks
|
7 Number of times comment made
|
8 Number of times comment made
|
|
Qualitative Outcome: Semi-Structured Interviews to Explore How Glucose Monitoring Affects Participants Thoughts and Feelings
Trouble with device
|
8 Number of times comment made
|
2 Number of times comment made
|
SECONDARY outcome
Timeframe: 2-4 weeks postpartum (up to 26 weeks on study)Explore if traditional management versus continuous glucose management has higher feelings of control over diabetes management. The interviews will be recorded and transcribed by the Survey Center and analyzed for theme and content by two reviewers for validity.
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Qualitative Outcome: Interviews to Understand Participant Sense of Control Around Glucose Monitoring
Feelings of blood glucose control
|
3 Number of times comment made
|
6 Number of times comment made
|
|
Qualitative Outcome: Interviews to Understand Participant Sense of Control Around Glucose Monitoring
Ability to control diet
|
1 Number of times comment made
|
6 Number of times comment made
|
|
Qualitative Outcome: Interviews to Understand Participant Sense of Control Around Glucose Monitoring
Tools to improve control available
|
4 Number of times comment made
|
0 Number of times comment made
|
|
Qualitative Outcome: Interviews to Understand Participant Sense of Control Around Glucose Monitoring
Trouble remembering to monitor glucose
|
7 Number of times comment made
|
4 Number of times comment made
|
SECONDARY outcome
Timeframe: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)Population: Some participants did not answer surveys at all timepoints.
A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You Currently With the Amount of Time it Takes to Manage Your Diabetes?
Enrollment
|
3.2 score on a scale
Standard Deviation 1.4
|
2.6 score on a scale
Standard Deviation 1.9
|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You Currently With the Amount of Time it Takes to Manage Your Diabetes?
28-32 weeks
|
1.7 score on a scale
Standard Deviation 0.8
|
2.2 score on a scale
Standard Deviation 1.3
|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You Currently With the Amount of Time it Takes to Manage Your Diabetes?
Postpartum
|
2.6 score on a scale
Standard Deviation 1.7
|
3.0 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)Population: Some participants did not answer surveys at all timepoints.
A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With the Time it Takes to Determine Your Sugar Level?
Enrollment
|
2.5 score on a scale
Standard Deviation 1.7
|
2.6 score on a scale
Standard Deviation 2.0
|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With the Time it Takes to Determine Your Sugar Level?
28-32 weeks
|
1.5 score on a scale
Standard Deviation 0.5
|
2.4 score on a scale
Standard Deviation 1.3
|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With the Time it Takes to Determine Your Sugar Level?
Postpartum
|
2.0 score on a scale
Standard Deviation 1.4
|
2.5 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)Population: Some participants did not answer surveys at all timepoints.
A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With the Total Time it Has Taken to Manage Your Diabetes Over the Last 2 Weeks?
Enrollment
|
3.4 score on a scale
Standard Deviation 1.9
|
2.6 score on a scale
Standard Deviation 1.9
|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With the Total Time it Has Taken to Manage Your Diabetes Over the Last 2 Weeks?
28-32 weeks
|
1.8 score on a scale
Standard Deviation 0.8
|
2.4 score on a scale
Standard Deviation 1.1
|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With the Total Time it Has Taken to Manage Your Diabetes Over the Last 2 Weeks?
Postpartum
|
2.9 score on a scale
Standard Deviation 1.8
|
2.8 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)Population: Some participants did not answer surveys at all timepoints.
A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With Your Current Diabetes Treatment?
Enrollment
|
2.6 score on a scale
Standard Deviation 1.3
|
2.0 score on a scale
Standard Deviation 0.8
|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With Your Current Diabetes Treatment?
28-32 weeks
|
1.8 score on a scale
Standard Deviation 0.8
|
1.8 score on a scale
Standard Deviation 1.3
|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With Your Current Diabetes Treatment?
Postpartum
|
1.9 score on a scale
Standard Deviation 0.7
|
2.0 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: at enrollment, 28-32 weeks gestation (10 to 14 weeks on study), 2-4 weeks postpartum (up to 26 weeks on study)Population: Some participants did not answer surveys at all timepoints.
A custom survey for Satisfaction and Quality of Life will be administered and answers will be compared between groups. Questions include answers on a 7-point Likert scale, where 1 = very dissatisfied and 7 = very satisfied
Outcome measures
| Measure |
Arm 1: Continuous Glucose Monitor (CGM)
n=8 Participants
CGM for duration of pregnancy.
|
Arm 2: Point of Care Glucose Testing (POCT)
n=8 Participants
Point of care finger sticks for glucose monitoring.
At two time points during the study - at time of enrollment and at 28-32 weeks gestation, CGM sensor will be placed and remain in place for 10 days. Participant and Physician will be blinded to CGM data.
|
|---|---|---|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With Time Spent Getting Checkups for Your Diabetes?
Enrollment
|
3.4 score on a scale
Standard Deviation 1.6
|
2.4 score on a scale
Standard Deviation 1.2
|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With Time Spent Getting Checkups for Your Diabetes?
28-32 weeks
|
1.7 score on a scale
Standard Deviation 1.0
|
2.0 score on a scale
Standard Deviation 1.2
|
|
Satisfaction and Quality of Life Survey - How Satisfied Are You With Time Spent Getting Checkups for Your Diabetes?
Postpartum
|
2.7 score on a scale
Standard Deviation 1.5
|
3.2 score on a scale
Standard Deviation 2.1
|
Adverse Events
Arm 1: Continuous Glucose Monitor (CGM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Point of Care Glucose Testing (POCT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place