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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523362
• Other study ID #: STUDY20221148
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 cross-over 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 information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ian J. Neeland, MD	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average glucose levels as measured by continuous glucose monitor	Average glucose on CGM	0, 30, 60, 90 days
Primary	Change in time in range as measured by continuous glucose monitor	Time in range on CGM	0, 30, 60, 90 days
Primary	Change in glucose variability as measured by continuous glucose monitor	Glucose variability on CGM	0, 30, 60, 90 days
Secondary	Change in Hemoglobin A1c from blood test	Glycosylated hemoglobin	0 and 90 days
Secondary	Change in Total cholesterol from blood test	Total cholesterol	0 and 90 days
Secondary	Change in Low density lipoprotein cholesterol from blood test	LDL-C	0 and 90 days
Secondary	Change in High density lipoprotein cholesterol from blood test	HDL-C	0 and 90 days
Secondary	Change in Triglycerides from blood test	Triglycerides	0 and 90 days
Secondary	Change in Body mass index from height and weight	BMI	0 and 90 days
Secondary	Change in Blood pressure from automated cuff	Systolic and diastolic blood pressure	0 and 90 days
Secondary	Picture Your Plate dietary assessment questionnaire	Picture Your PlateTM is a brief (48-question) dietary assessment questionnaire	90 days
Secondary	Type 2 Diabetes Distress Screening Scale (T2-DDAS)	The T2-DDAS is a self-report survey that has 29 items.	90 days
Secondary	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. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.	90 days
Secondary	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