Clinical trial NCT03620357: Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
Official title: Continuous Glucose Monitoring & Management In Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-08
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, multicenter, two-arm pilot study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HbA1c
timeFrame: From baseline to Month 3 (Week 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Diabetes/Lipid Management and Research Center
state: California
city: Temecula
country: United States
facility: Temecula Valley Endocrinology
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Baltimore
country: United States
facility: MODEL Clinical Research (Towson)
state: Maryland
city: Omaha
country: United States
facility: Diabetes & Endocrine Associates, PC
state: Nebraska
city: Henderson
country: United States
facility: Las Vegas Endocrinology
state: Nevada
city: Las Vegas
country: United States
facility: The Docs
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic
state: Texas
city: Toronto
country: Canada
facility: LMC Manna Research
state: Ontario
Study officials:
affiliation: DexCom, Inc.
name: David Price, MD
role: STUDY_DIRECTOR
References: