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

Sponsor

DexCom, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03620357

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

7.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Device: CGM Device: SMBG	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, multicenter, two-arm pilot study.Prospective, randomized, multicenter, two-arm pilot study.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Continuous Glucose Monitoring & Management In Type 2 Diabetes

Actual Study Start Date :

Sep 5, 2018

Actual Primary Completion Date :

May 27, 2020

Actual Study Completion Date :

Nov 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Continuous Glucose Monitor (CGM) Group	Device: CGM CGM Group: Dexcom G6 CGM
Active Comparator: SMBG Group	Device: SMBG SMBG Group: Blood Glucose Meter

Arm

Intervention/Treatment

Experimental: Continuous Glucose Monitor (CGM) Group

Device: CGM

CGM Group: Dexcom G6 CGM

Active Comparator: SMBG Group

Device: SMBG

SMBG Group: Blood Glucose Meter

Outcome Measures

Primary Outcome Measures

HbA1c [From baseline to Month 3 (Week 12)]
The primary endpoint is defined as change in HbA1c (determined by local lab or POC results).

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes/Lipid Management and Research Center	Huntington Beach	California	United States	92648
2	Temecula Valley Endocrinology	Temecula	California	United States	92592
3	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318
4	MODEL Clinical Research (Towson)	Baltimore	Maryland	United States	21204
5	Diabetes & Endocrine Associates, PC	Omaha	Nebraska	United States	68114
6	Las Vegas Endocrinology	Henderson	Nevada	United States	89052
7	The Docs	Las Vegas	Nevada	United States	89113
8	Palm Research Center	Las Vegas	Nevada	United States	89148
9	Diabetes and Glandular Disease Clinic	San Antonio	Texas	United States	78229
10	LMC Manna Research	Toronto	Ontario	Canada	M4G 3E8

Sponsors and Collaborators

DexCom, Inc.

Investigators

Study Director: David Price, MD, DexCom, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

DexCom, Inc.

ClinicalTrials.gov Identifier:

NCT03620357

Other Study ID Numbers:

PTL903076

First Posted:

Aug 8, 2018

Last Update Posted:

Mar 22, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 22, 2021