Trials / Completed
CompletedNCT02120794
Threshold Suspend in Pediatrics at Home
Multi-Center, Prospective, Observational Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System in Pediatric Patients With Type 1 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 194 (actual)
- Sponsor
- Medtronic MiniMed, Inc. · Industry
- Sex
- All
- Age
- 2 Years – 15 Years
- Healthy volunteers
- Not accepted
Summary
The study objective is to demonstrate that home use of Threshold Suspend (TS) is not associated with glycemic deterioration in pediatric patients with type 1 diabetes, as measured by change in A1C.
Detailed description
This study is a longitudinal, multi-center trial that aims to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump in patients 7-15 years with Type 1 diabetes. The study will measure the change in A1C from baseline over a period of one year while subjects are wearing the study pump.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 530G Insulin pump | Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2017-06-16
- Completion
- 2017-06-16
- First posted
- 2014-04-23
- Last updated
- 2018-09-11
- Results posted
- 2018-08-15
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02120794. Inclusion in this directory is not an endorsement.