Trial Outcomes & Findings for My Diabetes Study - CGM Initiation Approach & Time In Range (NCT NCT05928572)
NCT ID: NCT05928572
Last Updated: 2026-03-04
Results Overview
% time with glucose 70-180 mg/dL is a core CGM metric; it will be assessed between groups and will be described as the 24-hour period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
159 participants
Primary outcome timeframe
From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)
Results posted on
2026-03-04
Participant Flow
The trial was conducted by the International Diabetes Center (IDC) in an urban clinic setting (Minneapolis, MN). The first participant was enrolled and consented on July 25, 2023.
Once enrolled, participants begin baseline screening assessments. Participants had to meet glycated hemoglobin requirements and provide a minimum of 7 days of blinded CGM data in order to proceed with randomization and intervention participation. In some cases participants who consented/enrolled were not eligible to continue to randomization due to post-enrollment inclusion criteria. This is why more participants were enrolled than were assigned to each arm (N=159 versus N=132).
Participant milestones
| Measure |
Nutrition Focused Approach (NFA)
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Phase 1
STARTED
|
67
|
65
|
|
Phase 1
COMPLETED
|
64
|
60
|
|
Phase 1
NOT COMPLETED
|
3
|
5
|
|
Phase 2
STARTED
|
50
|
52
|
|
Phase 2
COMPLETED
|
50
|
52
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
My Diabetes Study - CGM Initiation Approach & Time In Range
Baseline characteristics by cohort
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 11.4 • n=41 Participants
|
64.6 years
STANDARD_DEVIATION 9.1 • n=35 Participants
|
65.0 years
STANDARD_DEVIATION 10.3 • n=76 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
43 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
81 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
6 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino/Latina/Latinx
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
2 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
White
|
59 Participants
n=41 Participants
|
47 Participants
n=35 Participants
|
106 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
A race ohter than listed above
|
3 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
8 Participants
n=76 Participants
|
|
Body Weight
|
94.3 Kgs
STANDARD_DEVIATION 19.3 • n=41 Participants
|
88.2 Kgs
STANDARD_DEVIATION 18.7 • n=35 Participants
|
91.3 Kgs
STANDARD_DEVIATION 19.3 • n=76 Participants
|
|
HbA1c
|
7.9 %
STANDARD_DEVIATION 0.7 • n=41 Participants
|
7.8 %
STANDARD_DEVIATION 0.7 • n=35 Participants
|
7.9 %
STANDARD_DEVIATION 0.7 • n=76 Participants
|
|
Time in Range
|
46 % of time with glucose 70-180mg/dL
STANDARD_DEVIATION 28 • n=41 Participants
|
55 % of time with glucose 70-180mg/dL
STANDARD_DEVIATION 27 • n=35 Participants
|
51 % of time with glucose 70-180mg/dL
STANDARD_DEVIATION 28 • n=76 Participants
|
PRIMARY outcome
Timeframe: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)% time with glucose 70-180 mg/dL is a core CGM metric; it will be assessed between groups and will be described as the 24-hour period
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Phase 1 Change in CGM-derived Time in Range (TIR)
|
25 % of time in 24 hours
Interval 16.0 to 34.0
|
16 % of time in 24 hours
Interval 7.0 to 25.0
|
SECONDARY outcome
Timeframe: Post-intervention period (day 40 to day 50)The total Healthy Eating Index is a measure of diet quality, independent of quantity, used to assess alignment of food intake with the Dietary Guidelines for Americans. HEI will be calculated using standard methods. The scale ranges 0-100; a total score of 100 is possible. Higher scores indicate higher quality diets (better nutritional intake). Differences between groups during the post-intervention period will be described.
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Total Healthy Eating Index (HEI) Score
|
65 units on a scale
Interval 61.0 to 68.0
|
63 units on a scale
Interval 60.0 to 67.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)% time above \>180 mg/dL is considered a core CGM metric; time above range. This will be described as the 24-hour period
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in CGM Derived % Time Above >180 mg/dL
|
-25 % time in 24 hours
Interval -34.0 to -17.0
|
-16 % time in 24 hours
Interval -25.0 to -6.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)% time above \>250 mg/dL is considered a core CGM metric; time above range. This will be described as the 24-hour period
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in CGM-derived % Time Above >250 mg/dL
|
-14 % time in 24 hours
Interval -19.0 to -9.0
|
-6 % time in 24 hours
Interval -12.0 to -1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)CGM-derived % time \<70 mg/dL is considered a core CGM metric; time below range This will be described as the 24-hour period
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in CGM-derived % Time Below <70 mg/dL
|
0.1 % time in 24 hours
Interval -0.07 to 0.27
|
-0.23 % time in 24 hours
Interval -0.4 to -0.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)Time in tight range is considered another CGM metric. This will be described as the 24-hour period
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in CGM-derived % Time in Tight Range (% Time With Glucose 70-140 mg/dL)
|
18 % time in 24 hours
Interval 10.0 to 26.0
|
12 % time in 24 hours
Interval 4.0 to 20.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11 to day 0) to post-intervention (day 40 to day 50)Describes the odds ratio for participants who reach consensus target or \>70% TIR (% time with glucose 70-180 mg/dL)
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Odds Ratio for Participants Reaching CGM-derived Consensus Targets by Arm
|
7.6 Odds ratio
Interval 3.3 to 17.4
|
3.1 Odds ratio
Interval 1.4 to 6.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11) to post-intervention (day 40 to day 50)Energy intake will be calculated using 24 hour dietary recalls
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in Total Energy Intake
|
-164 kilocalories
Interval -444.0 to 117.0
|
-132 kilocalories
Interval -421.0 to 157.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11) to post-intervention (day 40 to day 50)Carbohydrate intake will be calculated using 24 hour dietary recalls
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in Carbohydrate Intake
|
-40 Grams
Interval -74.0 to -7.0
|
-28 Grams
Interval -62.0 to 7.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11) to post-intervention (day 40 to day 50)Select micronutrient (calcium) intake will be calculated using 24 hour dietary recalls
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in Calcium Intake
|
-21 milligrams
Interval -200.0 to 159.0
|
-49 milligrams
Interval -234.0 to 136.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11) to post-intervention (day 50)Diabetes distress will be measured using the Diabetes Distress Scale-17 score as indicated by validated survey. The total DDS-17 scale allows for a range of scores from 1 to 6, with a minimum of 1 and a maximum total of 6. A lower score means less distress and is better. Scores less than 2 generally mean little to no distress. A minimal clinically important difference is considered and improvement or worsening of more than 0.25.
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in Total Diabetes Distress Scale-17 Score
|
-0.15 Composite score
Interval -0.39 to 0.1
|
-0.02 Composite score
Interval -0.37 to 0.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11) to post-intervention (day 50)HbA1c will be evaluated using point of care assessment
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in HbA1c
|
-0.6 % of glycated hemoglobin
Interval -0.8 to -0.4
|
-0.6 % of glycated hemoglobin
Interval -0.8 to -0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11) to post-intervention (day 50)Body weight based on calibrated study scale
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in Body Weight
|
-0.5 Kilograms
Interval -7.2 to 6.2
|
-1.7 Kilograms
Interval -8.6 to 5.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline (day -11) to post-intervention (day 50)kg/m\^2 will be used to calculate BMI
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-0.3 kg/m2
Interval -2.4 to 1.8
|
-0.7 kg/m2
Interval -2.8 to 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-intervention period (day 40 to day 50)Survey of care providers: what percent of content -- the intended intervention components -- were delivered
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=64 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=60 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Fidelity to the Intended Intervention
|
99 % of content delivered
Standard Deviation 0.02
|
100 % of content delivered
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From post-intervention (day 40 to day 50) to follow-up (day 170 to day 180)Population: N=50 in NFA due to withdrawals from the study and participants who did not provide adequate CGM data. N=52 in SDA due to withdrawals from the study and participants who did not provide adequate CGM data.
% time with glucose 70-180 mg/dL from post-intervention to 4-month follow-up
Outcome measures
| Measure |
Nutrition Focused Approach (NFA)
n=50 Participants
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Self Directed Approach (SDA)
n=52 Participants
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|
|
Change in Phase 2 CGM-derived Time in Range (TIR)
|
-13.5 % of day
Interval -22.6 to -4.3
|
-9.3 % of day
Interval -18.3 to -0.3
|
Adverse Events
Phase 2 - Nutrition Focused Approach (NFA)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 - Self Directed Approach (SDA)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 - Nutrition Focused Approach (NFA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 - Self Directed Approach (SDA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 2 - Nutrition Focused Approach (NFA)
n=50 participants at risk
Phase 2 for NFA was an observational follow-up period only. Participants ended the NFA intervention and did not receive any study-related care during the follow-up period. They returned to the clinic at the end of follow-up for assessments only.
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Phase 2 - Self Directed Approach (SDA)
n=52 participants at risk
Phase 2 for SDA was an observational follow-up period only. Participants ended the SDA intervention and did not receive any study-related care during the follow-up period. They returned to the clinic at the end of follow-up for assessments only.
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
Phase 1 - Nutrition Focused Approach (NFA)
n=64 participants at risk
Phase 1 for NFA was the active intervention period.
NFA arm participants were introduced to Continuous glucose monitoring (CGM) with specific emphasis placed on the CGM device as a tool to guide food choices. The NFA encouraged participants to identify and make food choices that aligned with evidence-based nutrition recommendations and that helped them to achieve glucose targets for people with T2D. The NFA was not a rigid food plan, but rather a flexible eating pattern appropriate for diverse populations.
|
Phase 1 - Self Directed Approach (SDA)
n=60 participants at risk
Phase 2 for SDA was the active intervention period.
The SDA arm was intended to reflect current CGM initiation practices, which focused on technical use of the CGM device and associated data. Participants in the SDA arm used CGM manufacturer-provided materials, and they were encouraged to use the CGM data in a way that felt useful for helping them to achieve glucose targets.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
0.00%
0/50 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
1.9%
1/52 • Number of events 1 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
0.00%
0/64 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
0.00%
0/60 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain mass
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
0.00%
0/52 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
0.00%
0/64 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
0.00%
0/60 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
|
Gastrointestinal disorders
Mild epigastric tenderness
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
0.00%
0/52 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
0.00%
0/64 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
0.00%
0/60 • Adverse events were collected from enrollment through the end of phase 2, an average of 190 days (e.g. enrollment on day -10 when consent signed through phase 2 follow-up ~day 180). AEs are reported in two phases; Phase 1 is the active intervention period and covers enrollment (day -10) through intervention end (~day 50) -- Phase 2 is an observation-only follow-up period with no intervention that covers from the period from after intervention through the end of follow-up (~day 51-180).
AEs were only reported if they were considered a Reportable AEs per protocol. Reportable AEs included (1) CGM sensor-related reactions or infections requiring treatment by a medical provider and/or prescription medication, (2) severe hypoglycemia defined as requiring assistance of another person, and (3) severe hyperglycemia if the event involved diabetic ketoacidosis or hyperosmolar hyperglycemic state as defined by Kitabchi et al. SAEs followed ClinicalTrials.gov definitions.
|
Other adverse events
Adverse event data not reported
Additional Information
Holly Willis
HealthPartners Institute, International Diabetes Center
Phone: 952-993-3219
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place