Continuous Monitoring and Control of Hypoglycemia (COACH)

Dexcom

Status: Unknown

Conditions: Diabetes

Treatments: Device: Continuous Glucose Monitoring (CGM)

Study type: Observational

Funder types: Industry

Identifiers

NCT03340831

PTL-901895

Details and patient eligibility

About

Evaluate safety of non-adjunctive CGM use in CGM naive participants.

Full description

The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any mild/severe hypoglycemic or DKA events and any details surrounding an event. Clinic visits at Months 6 and 12 will capture frequency of SMBG testing, A1C level and PRO information. CGM data will be obtained during the study to assess for CGM adherence.

Enrollment: 1,388 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Naïve to real-time CGM
• Type 1 or insulin-requiring Type 2 diabetes
• ≥ 2 years old

Exclusion criteria

• Use of RT-CGM, within the past 12 months
• Pregnancy
• Concomitant disease or condition that may compromise patient safety including and not limited to severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits, or ongoing treatment for a significant malignancy.
• Known (or suspected) significant allergy to medical grade adhesives
• Dialysis

Trial design

1,388 participants in 1 patient group

CGM/BGM Group

Description:

single-group, whereby participant is their own control. Use of a Blood Glucose Meter (BGM) for 6 months is compared to use of the G5 and G6 CGM System for 6 months, with collection of major diabetes related events (mild/severe hypoglycemia and DKA).

Treatment:

Device: Continuous Glucose Monitoring (CGM)