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

NCT ID: NCT05523362

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-11-30

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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexcom continuous glucose monitor

Intervention Type: DEVICE

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

Interventions

Dexcom continuous glucose monitor

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Ian J. Neeland, MD

OTHER

Sponsor Role: lead

Responsible Party

Ian J. Neeland, MD

Director, UH Center for Cardiovascular Prevention

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ian Neeland, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY20221148

Identifier Type: -

Identifier Source: org_study_id