Trial Outcomes & Findings for Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes (NCT NCT05523362)

NCT ID: NCT05523362

Last Updated: 2024-08-06

Results Overview

Average glucose on CGM

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 56 participants
• Primary outcome timeframe: 0, 30, 60, 90 days
• Results posted on: 2024-08-06

Participant Flow

2 people did not meet eligibility criteria. They were consented but did not participate in the study. A total of 56 participants signed consents and only 47 fully completed both phases of the study.

Participant milestones

Measure	Dexcom G6 Continuous Glucose Monitoring Device During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase.
Phase 1- Blinded (10 Days) STARTED	56
Phase 1- Blinded (10 Days) COMPLETED	47
Phase 1- Blinded (10 Days) NOT COMPLETED	9
Phase 2- Unblinded (3 Months) STARTED	47
Phase 2- Unblinded (3 Months) COMPLETED	47
Phase 2- Unblinded (3 Months) NOT COMPLETED	0

Reasons for withdrawal

Measure	Dexcom G6 Continuous Glucose Monitoring Device During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase.
Phase 1- Blinded (10 Days) Unable to contact	2
Phase 1- Blinded (10 Days) High stress, did not want to continue	1
Phase 1- Blinded (10 Days) Technical issues with device	4
Phase 1- Blinded (10 Days) did not meet eligibility criteria	2

Baseline Characteristics

Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for Type 2 Diabetes

Baseline characteristics by cohort

Measure	Blinded Followed by Unblinded n=56 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Sex: Female, Male Male	32 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	19 Participants n=93 Participants
Race (NIH/OMB) White	32 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants
Age, Continuous	63 years STANDARD_DEVIATION 9.7 • n=93 Participants
Sex: Female, Male Female	24 Participants n=93 Participants

PRIMARY outcome

Timeframe: 0, 30, 60, 90 days

Average glucose on CGM

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor Day 0	184 mg/dl Standard Deviation 55.7
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor Day 30	148.6 mg/dl Standard Deviation 45.4
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor Day 60	144.8 mg/dl Standard Deviation 45.3
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor Day 90	147.2 mg/dl Standard Deviation 44.7

PRIMARY outcome

Timeframe: 0, 30, 60, 90 days

Time in range is the time spent in the acceptable glucose range between 80-180 mg/dl. This time in range is noted as a proportion of time that the blood glucose is in this range out of the total time. So if the person's glucose is in this range 70% of the time (and out of it 30%), then Time in Range is 70%.

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Time in Range as Measured by Continuous Glucose Monitor Day 0	57.8 percentage of time in range Standard Deviation 32.5
Change in Time in Range as Measured by Continuous Glucose Monitor Day 30	82 percentage of time in range Standard Deviation 22.7
Change in Time in Range as Measured by Continuous Glucose Monitor Day 60	83.8 percentage of time in range Standard Deviation 23.8
Change in Time in Range as Measured by Continuous Glucose Monitor Day 90	82.5 percentage of time in range Standard Deviation 24.6

PRIMARY outcome

Timeframe: 0, 30, 60, 90 days

Glucose variability on CGM is defined as standard deviation of the all recorded glucose values.

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Glucose Variability as Measured by Continuous Glucose Monitor Day 90	24 mg/dl Standard Deviation 6.6
Change in Glucose Variability as Measured by Continuous Glucose Monitor Day 0	26.2 mg/dl Standard Deviation 8.9
Change in Glucose Variability as Measured by Continuous Glucose Monitor Day 30	24.1 mg/dl Standard Deviation 7.5
Change in Glucose Variability as Measured by Continuous Glucose Monitor Day 60	24.1 mg/dl Standard Deviation 7.7

SECONDARY outcome

Timeframe: 0 and 90 days

Glycosylated hemoglobin

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Hemoglobin A1c From Blood Test Day 0	8.4 percentage of Glycosylated hemoglobin Standard Deviation 1.8
Change in Hemoglobin A1c From Blood Test Day 90	6.9 percentage of Glycosylated hemoglobin Standard Deviation 1.2

SECONDARY outcome

Timeframe: 0 and 90 days

Total cholesterol

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Total Cholesterol From Blood Test Day 0	162.6 mg/dl Standard Deviation 45.6
Change in Total Cholesterol From Blood Test Day 90	143.6 mg/dl Standard Deviation 45.2

SECONDARY outcome

Timeframe: 0 and 90 days

LDL-C

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Low Density Lipoprotein Cholesterol From Blood Test Day 0	82.8 mg/dl Standard Deviation 37
Change in Low Density Lipoprotein Cholesterol From Blood Test Day 90	73.6 mg/dl Standard Deviation 38.5

SECONDARY outcome

Timeframe: 0 and 90 days

HDL-C

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in High Density Lipoprotein Cholesterol From Blood Test Day 0	45.5 mg/dl Standard Deviation 12.4
Change in High Density Lipoprotein Cholesterol From Blood Test Day 90	43.9 mg/dl Standard Deviation 10.5

SECONDARY outcome

Timeframe: 0 and 90 days

Triglycerides

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Triglycerides From Blood Test Day 0	173.3 mg/dl Standard Deviation 110.4
Change in Triglycerides From Blood Test Day 90	131.2 mg/dl Standard Deviation 69.7

SECONDARY outcome

Timeframe: 0 and 90 days

BMI

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Body Mass Index From Height and Weight Day 0	37.7 kg/m2 Standard Deviation 6.1
Change in Body Mass Index From Height and Weight Day 90	34.9 kg/m2 Standard Deviation 5.9

SECONDARY outcome

Timeframe: 0 and 90 days

Systolic blood pressure

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Systolic Blood Pressure From Automated Cuff Day 0	134.8 mmHg Standard Deviation 16.3
Change in Systolic Blood Pressure From Automated Cuff Day 90	126.0 mmHg Standard Deviation 15.2

SECONDARY outcome

Timeframe: 0 and 90 days

Diastolic blood pressure

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Change in Diastolic Blood Pressure From Automated Cuff Day 0	79.4 mmHg Standard Deviation 6.7
Change in Diastolic Blood Pressure From Automated Cuff Day 90	75.8 mmHg Standard Deviation 7.3

SECONDARY outcome

Timeframe: 0, 90 days

Picture Your PlateTM is a brief (48-question) dietary assessment questionnaire developed to assess how well an individual's eating habits align with current evidence-based recommendations. Picture Your Plate provides a total score ranging from 0 to 96, with a higher score indicating healthier food choice awareness.

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Picture Your Plate Dietary Assessment Questionnaire Day 0	61 score on a scale Standard Deviation 12.4
Picture Your Plate Dietary Assessment Questionnaire Day 90	65.5 score on a scale Standard Deviation 17.7

SECONDARY outcome

Timeframe: 0, 90 days

The T2-DDAS is a self-report survey that has 29 items. Each item rated on a 1 to 5 scale:

Mean score < 2.0 indicate little or no distress.

Mean score between 2.0 and 2.9 indicate moderate distress.

Mean score > 3.0 indicate high distress

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
Type 2 Diabetes Distress Screening Scale (T2-DDAS) Day 0	2.4 score on a scale Standard Deviation 0.9
Type 2 Diabetes Distress Screening Scale (T2-DDAS) Day 90	1.6 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 0, 90 days

The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires.

Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. This measure assesses the types of intensity of physical activity that people do as part of their daily lives. The estimate is measured as total physical activity in MET-min/week. Lower scores mean less total amount and intensity of physical activity and higher scores mean greater total amount and intensity of physical activity in a given week.

Outcome measures

Measure	Blinded Followed by Unblinded n=47 Participants During Phase 1 (10 days), the patient wears the Dexcom G6 Pro CGM in blinded mode and is unaware and unable to access the data. The patient performs standard care, self-monitoring with twice daily glucose checks using standard finger-sticks and a glucometer device. During this phase, the medical providers are also blinded to the CGM data and continue standard care without any specific intervention. During Phase 2 (3 months), the patient wears the Dexcom G6 Personal CGM in un-blinded mode and the medical providers have access to the data via Clarity and/or direct download via the transmitter. CGM data are collected continuously in each phase and at the end of each phase. Dexcom continuous glucose monitor: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.
International Physical Activity Questionnaire (IPAQ) Day 0	2864.8 minutes per week Standard Deviation 3329
International Physical Activity Questionnaire (IPAQ) Day 90	3445.4 minutes per week Standard Deviation 3040

SECONDARY outcome

Timeframe: 90 days

Population: No data was collected.

The GMSS is a reliable, valid measure of glucose device satisfaction in its T1D form and in its insulin-using T2D form. It provides a comprehensive profile of sources of device satisfaction for use in clinical care and research.

Outcome measures

Outcome data not reported

Adverse Events

Blinded

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unblinded

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

Dr. Ian Neeland

University Hospitals Cleveland Medical Center

Phone: (216)844-5965

Email: Ian.Neeland@UHhospitals.org

Results disclosure agreements

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