Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) (COMMITED)
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|ClinicalTrials.gov Identifier: NCT03620357|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2018
Last Update Posted : January 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Device: CGM Device: SMBG||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, randomized, multicenter, two-arm confirmatory study.|
|Masking:||None (Open Label)|
|Official Title:||Continuous Glucose Monitoring & Management In Type 2 Diabetes|
|Actual Study Start Date :||September 5, 2018|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||December 31, 2020|
|Experimental: Continuous Glucose Monitor (CGM) Group||
CGM Group: Dexcom G6 CGM
|Active Comparator: SMBG Group||
SMBG Group: Blood Glucose Meter
- HbA1c [ Time Frame: From baseline to Month 3 (Week 12) and to Month 9 (Week 36). ]The primary endpoint is defined as change in HbA1c (determined by local lab or POC results).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620357
|United States, California|
|Diabetes/Lipid Managment and Research Center|
|Huntington Beach, California, United States, 92648|
|Bill L Jou, M.D. Inc.|
|Temecula, California, United States, 92592|
|United States, Georgia|
|Atlanta Diabetes Associates|
|Atlanta, Georgia, United States, 30318|
|United States, Maryland|
|MODEL Clinical Research (Towson)|
|Baltimore, Maryland, United States, 21204|
|United States, Nebraska|
|Diabetes & Endocrine Associates, PC|
|Omaha, Nebraska, United States, 68114|
|United States, Nevada|
|Las Vegas Endocrinology|
|Henderson, Nevada, United States, 89052|
|Las Vegas, Nevada, United States, 89113|
|Palm Research Center|
|Las Vegas, Nevada, United States, 89148|
|United States, Texas|
|Diabetes and Glandular Disease Clinic|
|San Antonio, Texas, United States, 78229|
|Study Director:||David Price, MD||DexCom, Inc.|