Trial Outcomes & Findings for Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation (NCT NCT05404711)

NCT ID: NCT05404711

Last Updated: 2024-09-25

Results Overview

Completeness of CGM data (≥ 80% of days with data)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 10 days
• Results posted on: 2024-09-25

Participant Flow

Participant milestones

Measure	CGM Use for T2D Risk Evaluation All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.
Completed Study Visit STARTED	40
Completed Study Visit COMPLETED	39
Completed Study Visit NOT COMPLETED	1
Completed 75-gram, 2-hour CGM-OGTT STARTED	39
Completed 75-gram, 2-hour CGM-OGTT COMPLETED	35
Completed 75-gram, 2-hour CGM-OGTT NOT COMPLETED	4
Valid 75-gram, 2-hour CGM-OGTT STARTED	35
Valid 75-gram, 2-hour CGM-OGTT COMPLETED	30
Valid 75-gram, 2-hour CGM-OGTT NOT COMPLETED	5
Completed, Valid Lab-OGTT and CGM-OGTT STARTED	30
Completed, Valid Lab-OGTT and CGM-OGTT COMPLETED	29
Completed, Valid Lab-OGTT and CGM-OGTT NOT COMPLETED	1

Reasons for withdrawal

Measure	CGM Use for T2D Risk Evaluation All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.
Completed Study Visit Withdrawal by Subject	1
Completed 75-gram, 2-hour CGM-OGTT Incomplete due to illness	1
Completed 75-gram, 2-hour CGM-OGTT CGM fell off early	3
Valid 75-gram, 2-hour CGM-OGTT No date/time recorded	4
Valid 75-gram, 2-hour CGM-OGTT Vomited after drinking glucose beverage at home	1
Completed, Valid Lab-OGTT and CGM-OGTT Incomplete glucose beverage for lab-OGTT	1

Baseline Characteristics

Continuous Glucose Monitors (CGM) for Type 2 Diabetes (T2D) Risk Evaluation

Baseline characteristics by cohort

Measure	CGM Use for T2D Risk Evaluation n=39 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.
Age, Continuous	14.6 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · non-Hispanic White	18 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · non-Hispanic Black	13 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · multi-racial	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Latinx	3 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants
BMI	35.9 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Population: Of the 39 participants who completed the study visit, 38 returned their CGM for analysis.

Completeness of CGM data (≥ 80% of days with data)

Outcome measures

Measure	CGM Use for T2D Risk Evaluation n=38 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.
Feasibility of CGM Use to Determine Type 2 Diabetes Risk CGM Wear ≥ 8 Days	33 Participants
Feasibility of CGM Use to Determine Type 2 Diabetes Risk CGM Wear < 8 Days	5 Participants

SECONDARY outcome

Timeframe: 30 minutes

Population: Of the 39 participants enrolled in the study, only 36 completed the exit interview.

Interview-based assessment. Participants rated their experience with CGM-OGTT using a Likert-like scale from 1-5 (1= terrible, 2=bad, 3=neutral, 4=good, 5=excellent). Acceptability was defined as a pre-specified threshold of ≥80% of participants providing a neutral or higher rating.

Outcome measures

Measure	CGM Use for T2D Risk Evaluation n=36 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.
Acceptability of CGM Use for At-home T2D Risk Evaluation in Youth Rated as excellent/good	33 Participants
Acceptability of CGM Use for At-home T2D Risk Evaluation in Youth Rated as neutral	3 Participants

SECONDARY outcome

Timeframe: 2 Hour Point of Home-OGTT

Sensitivity of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=29 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Sensitivity of At-home CGM-measured Glucose Challenge

80 percentage of true positives

SECONDARY outcome

Timeframe: 2 Hour Point of Home-OGTT

Specificity of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=29 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Specificity of At-home CGM-measured Glucose Challenge

25 percentage of true negatives

SECONDARY outcome

Timeframe: 2 Hour Point of Home-OGTT

Positive predictive value of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=29 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Positive Predictive Value of At-home, CGM-measured Glucose Challenge

18.2 percent accuracy of positive tests

SECONDARY outcome

Timeframe: 2 Hour Point of Home-OGTT

Negative predictive value of CGM-glucose 2 hours after at-home glucose beverage ingestion to predict OGTT-2h≥140 mg/dL

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=29 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Negative Predictive Value of At-home, CGM-measured Glucose Challenge

85.7 percent accuracy of negative tests

SECONDARY outcome

Timeframe: 5 Minute Point of Home-OGTT

Population: Of the 35 participants completing the 2-hr CGM-OGTT, 31 had valid data for baseline fasting glucose.

Sensitivity of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=31 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Sensitivity of At-home CGM-measured Fasting Glucose

100 percentage of true positives

SECONDARY outcome

Timeframe: 5 Minute Point of Home-OGTT

Population: Of the 35 participants completing the 2-hr CGM-OGTT, 31 had valid data for baseline fasting glucose.

Specificity of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=31 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Specificity of At-home CGM-measured Fasting Glucose

10 percentage of true negatives

SECONDARY outcome

Timeframe: 5 Minute Point of Home-OGTT

Population: Of the 35 participants completing the 2-hr CGM-OGTT, 31 had valid data for baseline fasting glucose.

Positive predictive value of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=31 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Positive Predictive Value of At-home CGM-measured Fasting Glucose

3.6 percent accuracy of positive tests

SECONDARY outcome

Timeframe: 5 Minute Point of Home-OGTT

Population: Of the 35 participants completing the 2-hr CGM-OGTT, 31 had valid data for baseline fasting glucose.

Negative predictive value of baseline CGM-glucose at the time of at-home glucose beverage ingestion to predict fasting OGTT ≥100 mg/dL

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=31 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Negative Predictive Value of At-home CGM-measured Fasting Glucose

100 percent accuracy of negative tests

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at Research Visit

HbA1c will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge.

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=39 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Laboratory-measured HbA1c

5.7 percent Interval 5.4 to 5.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Start of Lab-OGTT

Fasting glucose will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge.

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=39 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Laboratory-measured Fasting Glucose

84 mg/dL Interval 80.0 to 91.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Hour Point of Lab-OGTT

2-hour OGTT glucose will be measured in the laboratory at baseline to investigate associations with CGM indices obtained during at-home glucose challenge.

Outcome measures

Measure

CGM Use for T2D Risk Evaluation n=39 Participants All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.

Laboratory-measured 2-hour Glucose

112 mg/dL Interval 101.0 to 126.0

Adverse Events

CGM Use for T2D Risk Evaluation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CGM Use for T2D Risk Evaluation n=39 participants at risk All participants will complete a standard 2-hour oral glucose tolerance test (OGTT), wear a CGM for 10 days, complete at-home glucose challenge, and provide qualitative feedback about their experiences with both OGTT and CGM use for risk evaluation. CGM: Participants will wear blinded Dexcom G6 Pro continuously for 10 days in their home environment. Two challenges will be completed at home: 1) glucose, using 1.75 g/kg (max 75g) glucose beverage provided by study team, and 2) mixed food, containing 50g carb as well as protein and fat content of participant's choice.
Skin and subcutaneous tissue disorders Rash due to CGM adhesive	5.1% 2/39 • Adverse event information was collected for the study duration of 10 days.
General disorders Emesis due to OGTT beverage	2.6% 1/39 • Adverse event information was collected for the study duration of 10 days.

Additional Information

Mary Ellen Vajravelu, MD,MSHP

University of Pittsburgh School of Medicine

Phone: 412-692-6533

Email: vajravelume@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place