Trials / Unknown
UnknownNCT03340831
Continuous Monitoring and Control of Hypoglycemia
Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,388 (estimated)
- Sponsor
- DexCom, Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Continuous Glucose Monitoring (CGM) | Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM) |
Timeline
- Start date
- 2017-10-20
- Primary completion
- 2023-12-30
- Completion
- 2023-12-30
- First posted
- 2017-11-14
- Last updated
- 2021-09-21
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03340831. Inclusion in this directory is not an endorsement.