CGM for Type 2 Diabetes

(CMGProject Trial)

Overseen By Thomas Grace, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Blanchard Valley Health System

Must not be taking: Glucocorticoids

Disqualifiers: Pregnancy, Renal disease, Visual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators believe that addition of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome in patients with Type 2 diabetes compared to self-monitored blood glucose (SMBG), for patients who are not at target A1C regardless of treatment modality. The investigators aims to assess glycemic and quality of life (QoL) benefits of adding and using RT-CGM patients with Type 2 Diabetes Mellitus (T2DM), not at their A1C goal and relying on SMBG for diabetes-management decisions.

Research Team

Thomas Grace, MD

Principal Investigator

Hancock County Health Department

Eligibility Criteria

Adults with Type 2 Diabetes not meeting their A1C goals (A1C ≥7.7%) despite regular doctor visits and a desire to improve control are eligible for this trial. They must be willing to wear a continuous glucose monitor (CGM) and have stable diabetes management, as judged by the investigator. Pregnant individuals, those with certain medical conditions or severe allergies to adhesives, and anyone using CGMs in the last 3 months are excluded.

Inclusion Criteria

Followed regularly by a physician with at least 2 office visits in last year as documented by clinical history

I have been diagnosed with type 2 diabetes.

My blood sugar control is poor, with an A1C level of 7.7% or higher.

Exclusion Criteria

Current participation in another investigational study within the last 30 days

I have been using a real-time CGM device for the last 3 months.

Any condition per investigator assessment that could impact reliability of the A1C measurement

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Prescreening period

Treatment

Participants receive real-time continuous glucose monitoring (RT-CGM) and basic CGM education

12 months

Visits every 3 months for CGM supplies and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dexcom G6 CGM

Trial Overview The study is testing if real-time continuous glucose monitoring (RT-CGM) can better manage blood sugar levels compared to standard self-monitoring in people with Type 2 Diabetes who aren't reaching their target A1C levels. It also looks at how RT-CGM affects quality of life.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

All participants will be given a rtCGM (Dexcom G6) to assess their glycemic control.

Who Is Running the Clinical Trial?

Blanchard Valley Health System

Lead Sponsor

Trials

1

Recruited

200+