DexCom, Inc.
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.
Diabetes Mellitus, Type 2
CGM
SMBG
NA
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 |
Estimated Enrollment : | 72 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | Continuous Glucose Monitoring & Management In Type 2 Diabetes |
Actual Study Start Date : | 2018-09-05 |
Estimated Primary Completion Date : | 2020-05-27 |
Estimated Study Completion Date : | 2020-11-04 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 30 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States, 92648
Not yet recruiting
Temecula Valley Endocrinology
Temecula, California, United States, 92592
Not yet recruiting
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Not yet recruiting
MODEL Clinical Research (Towson)
Baltimore, Maryland, United States, 21204
Not yet recruiting
Diabetes & Endocrine Associates, PC
Omaha, Nebraska, United States, 68114
Not yet recruiting
Las Vegas Endocrinology
Henderson, Nevada, United States, 89052
Not yet recruiting
The Docs
vegas, Nevada, United States, 89113
Not yet recruiting
Palm Research Center
vegas, Nevada, United States, 89148
Not yet recruiting
Diabetes and Glandular Disease Clinic
Saint Anthony, Texas, United States, 78229
Not yet recruiting
LMC Manna Research
Toronto, Ontario, Canada, M4G 3E8