Trials / Completed
CompletedNCT06604871
Safety Evaluation of MiniMed™ 780G System With DS5 CGM in Children
Safety Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM in Children 2-6 Years of Age
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Medtronic MiniMed, Inc. · Industry
- Sex
- All
- Age
- 2 Years – 6 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 pediatric subjects (2-6 years of age) in a home setting.
Detailed description
This study is a multi-center, single arm study in insulin-requiring pediatric subjects with type 1 diabetes on the MiniMed 780G system using DS5. The run-in period and study period, together, will be approximately 130 days long.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Insulin Pump with Continuous Glucose Monitoring | MiniMed™ 780G insulin pump in combination with the DS5 CGM |
Timeline
- Start date
- 2024-10-29
- Primary completion
- 2025-09-26
- Completion
- 2025-09-26
- First posted
- 2024-09-20
- Last updated
- 2025-10-08
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06604871. Inclusion in this directory is not an endorsement.