Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)

Diabetes Mellitus, Type 2 Clinical Trial

— COMMITED  

Official title:

Continuous Glucose Monitoring & Management In Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620357
• Other study ID #: PTL903076
• Status: Completed
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: November 4, 2020

Study information

• Verified date: March 2021
• Source: DexCom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Study to assess if patients with Type 2 diabetes (T2D) who have suboptimal glycemic control using multiple oral agents are able to make lifestyle changes resulting in improved glycemic control by use of real-time continuous glucose monitoring (RT-CGM) and targeted learning modules versus self monitored blood glucose (SMBG) testing.

Description:

The study is referred to as "Continuous Glucose Monitoring and Management in Type 2 Diabetes" also known as The COMMITED Study" and will assess if patients with Type 2 diabetes (T2D) who have suboptimal glycemic control using 2 or more multiple oral agents are able to make lifestyle changes resulting in improved glycemic control by use of real-time continuous glucose monitoring and targeted learning modules.

At time of enrollment, participants will undergo a run-in period of blinded CGM for a duration of 10 days to collect baseline data. Baseline Patient Report Outcome (PRO) surveys will be administered at the start of run-in.

The study design includes a run-in phase, a study phase and a follow up visit. During the study phase, participants will be randomized into two groups - CGM Group or SMBG Group. For the RT-CGM Group, the study comprises of 4 scheduled clinic visits at baseline (after Run-In), week 4, week 8, and week 12 to collect data on episodic RT-CGM use. During these visits, RT-CGM insertions will take place at baseline, week 4 and week 8 clinic visits, with each wear period lasting a duration of 10 days. For the SMBG Group, the study comprises of 3 scheduled clinic visits at baseline (after Run-In), week 8 (to collect data on episodic blinded CGM use) and week 12. CGM insertions will take place at week 8 with a wear period of 10 days. Both groups will have HbA1c collected at week 0 and week 12. The same PRO surveys administered at start of run-in will be administered again at week 12. There will not be therapeutic changes during the study phase unless needed for safety.

There will be phone/remote visits by a study site clinician at weeks 2, 6 and 10 in both groups to review the SMBG or CGM data. During these remote visits, there will be discussions about what the subjects have learned from their glucose monitoring and what the study clinician has observed.

All subjects will be scheduled for a follow up visit at Month 9 to obtain local lab or POC HbA1c. Diabetes medications (classifications only) will also be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 4, 2020
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Major Inclusion Criteria:

• Age at least 30 years

• Diagnosis of T2D treated with 2 or more oral anti-diabetic medications

• HbA1c = 7.8 and =10.5% by local lab or POC

Major Exclusion Criteria:

• Using insulin

• Pregnancy

• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• CGM
CGM Group: Dexcom G6 CGM
• SMBG
SMBG Group: Blood Glucose Meter

Locations

Country	Name	City	State
Canada	LMC Manna Research	Toronto	Ontario
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	MODEL Clinical Research (Towson)	Baltimore	Maryland
United States	Las Vegas Endocrinology	Henderson	Nevada
United States	Diabetes/Lipid Management and Research Center	Huntington Beach	California
United States	Palm Research Center	Las Vegas	Nevada
United States	The Docs	Las Vegas	Nevada
United States	Diabetes & Endocrine Associates, PC	Omaha	Nebraska
United States	Diabetes and Glandular Disease Clinic	San Antonio	Texas
United States	Temecula Valley Endocrinology	Temecula	California

Sponsors (1)

Lead Sponsor	Collaborator
DexCom, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	The primary endpoint is defined as change in HbA1c (determined by local lab or POC results).	From baseline to Month 3 (Week 12)