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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CGM
SMBG
Sponsored by
DexCom, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Diabetes/Lipid Management and Research Center
  • Temecula Valley Endocrinology
  • Atlanta Diabetes Associates
  • MODEL Clinical Research (Towson)
  • Diabetes & Endocrine Associates, PC
  • Las Vegas Endocrinology
  • The Docs
  • Palm Research Center
  • Diabetes and Glandular Disease Clinic
  • LMC Manna Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous Glucose Monitor (CGM) Group

SMBG Group

Arm Description

Outcomes

Primary Outcome Measures

HbA1c
The primary endpoint is defined as change in HbA1c (determined by local lab or POC results).

Secondary Outcome Measures

Full Information

First Posted
July 31, 2018
Last Updated
March 18, 2021
Sponsor
DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03620357
Brief Title
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
Acronym
COMMITED
Official Title
Continuous Glucose Monitoring & Management In Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
May 27, 2020 (Actual)
Study Completion Date
November 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DexCom, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, multicenter, two-arm pilot study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Glucose Monitor (CGM) Group
Arm Type
Experimental
Arm Title
SMBG Group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
CGM
Intervention Description
CGM Group: Dexcom G6 CGM
Intervention Type
Device
Intervention Name(s)
SMBG
Intervention Description
SMBG Group: Blood Glucose Meter
Primary Outcome Measure Information:
Title
HbA1c
Description
The primary endpoint is defined as change in HbA1c (determined by local lab or POC results).
Time Frame
From baseline to Month 3 (Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Price, MD
Organizational Affiliation
DexCom, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Diabetes/Lipid Management and Research Center
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Temecula Valley Endocrinology
City
Temecula
State/Province
California
ZIP/Postal Code
92592
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
MODEL Clinical Research (Towson)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Diabetes & Endocrine Associates, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Las Vegas Endocrinology
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
The Docs
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Palm Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Diabetes and Glandular Disease Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
LMC Manna Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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