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

Feasibility and Clinical Utility of the Dexcom G6 Continuous Glucose Monitoring Device for the Care of Patients With Type 2 Diabetes Not Using Insulin Therapy

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Dexcom continuous glucose monitor

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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Blinded followed by Unblinded; 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.

Device: Dexcom continuous glucose monitor; The investigational device used in this study is the Dexcom G6 Pro/Personal Continuous Blood Glucose Monitoring system.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ian J. Neeland, MD
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Ian Neeland, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY20221148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No