Assessing Non-adjunctive CGM Safety at Home and in New Markets

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Phase 1- Introduction to Dexcom G6 CGM

• Registration Number: NCT04585139
• Lead Sponsor: DexCom, Inc.

Brief Summary

The purpose of the study is to examine whether non-adjunctive (without having to double check using another method) use of Continuous Glucose Monitoring improves A1c in adults or children with diabetes managed by intensive insulin therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-05
• Study Start: 2020-10-06
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-14
• Primary Completion: 2022-02-07
• Study Completion: 2022-02-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1 -- Introduction to Dexcom G6 CGM	Phase 1- Introduction to Dexcom G6 CGM	A 2 week run-in wear period of blinded CGM followed by 12 weeks of wear of a Commercially available CGM
Phase 2 -- Comparison of an Updated G6 Transmitter to Commercial Dexcom G6 CGM	Phase 1- Introduction to Dexcom G6 CGM	1 group will wear a Commercially available CGM for 12 weeks while the 2 group will wear an Updated CGM for 12 weeks.

Primary Outcome Measures

Name	Time	Method
HbA1c	16 weeks	Phase 1 change in HbA1c for the adult cohort only.

Trial Locations

Locations (1)

Las Vegas Endocrinology; 🇺🇸 Henderson, Nevada, United States