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

Not Applicable

Completed

Conditions: Type 2 Diabetes

Interventions: Device: Dexcom continuous glucose monitor

Registration Number: NCT05523362

Lead Sponsor: Ian J. Neeland, MD

Brief Summary: The objective of this study is to evaluate the feasibility and clinical utility of a continuous glucose monitoring device (CGM, Dexcom G6) for the care of patients with type 2 diabetes who are on non-insulin therapies.

Detailed Description: The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.

This investigation is a 2-phase sequential study with patients serving as their own controls. The demographics, medical history, anthropometric and laboratory data are collected at baseline for each patient. 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. Anthropometric and laboratory data (including HB A1c) are collected. Medical providers are also un-blinded and adjust medical recommendations and interventions, in part based on CGM data, as appropriate.

All patients will receive usual care which will include individual and virtual lifestyle education, virtual support group, M.D. visits, medication interventions, referrals to support programs outside the scope of CINEMA program and nursing support

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 56

Inclusion Criteria

Type 2 diabetes of any duration
Hb A1c ≥ 7% (no upper limit)
BMI ≥ 30 kg/m2
Ability to wear CGM (e.g. no dermatological issue precluding device insertion)
Access to a smartphone device

Exclusion Criteria

Any insulin use in the past 3 months
Planned use of insulin in the next 6 months
Presence of a blood disorder (such as sickle cell anemia) making glycosylated hemoglobin measurement inaccurate
Current use of a weight loss medication
Unable or uncomfortable with wearing a CGM device

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blinded followed by Unblinded	Dexcom continuous glucose monitor	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.

Primary Outcome Measures

Name	Time	Method
Change in Average Glucose Levels as Measured by Continuous Glucose Monitor	0, 30, 60, 90 days	Average glucose on CGM
Change in Glucose Variability as Measured by Continuous Glucose Monitor	0, 30, 60, 90 days	Glucose variability on CGM is defined as standard deviation of the all recorded glucose values.
Change in Time in Range as Measured by Continuous Glucose Monitor	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%.

Secondary Outcome Measures

Name	Time	Method
Change in Total Cholesterol From Blood Test	0 and 90 days	Total cholesterol
Change in Low Density Lipoprotein Cholesterol From Blood Test	0 and 90 days	LDL-C
Change in High Density Lipoprotein Cholesterol From Blood Test	0 and 90 days	HDL-C
Change in Hemoglobin A1c From Blood Test	0 and 90 days	Glycosylated hemoglobin
Change in Body Mass Index From Height and Weight	0 and 90 days	BMI
Change in Systolic Blood Pressure From Automated Cuff	0 and 90 days	Systolic blood pressure
Change in Diastolic Blood Pressure From Automated Cuff	0 and 90 days	Diastolic blood pressure
Type 2 Diabetes Distress Screening Scale (T2-DDAS)	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
International Physical Activity Questionnaire (IPAQ)	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.
Change in Triglycerides From Blood Test	0 and 90 days	Triglycerides
Picture Your Plate Dietary Assessment Questionnaire	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.
Glucose Monitoring Satisfaction Survey	90 days	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.