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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03620357
Other study ID # PTL903076
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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