Trials / Completed
CompletedNCT02733991
Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Medtronic MiniMed, Inc. · Industry
- Sex
- All
- Age
- 24 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A premarket, international multicenter, prospective, open label, adaptive, randomized controlled study. The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia. The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at evaluating the difference in glycemic parameters and HbA1c.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MiniMed™640G and Suspend before low | All enrolled subjects will start a run in phase, receive training and start pump therapy with the MiniMed™640G insulin pump and usage of blinded Continuous Glucose Monitoring. Eligible subjects that meet the randomization criteria assessed after the running phase will be randomized into the treatment or control arm. Treatment Arm: training and start of Sensor Augmented Pump therapy with Suspend before Low feature of SmartGuard turned ON. Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks during the treatment phase. |
| DEVICE | MiniMed™640G | Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks. |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2018-10-01
- Completion
- 2018-10-01
- First posted
- 2016-04-12
- Last updated
- 2020-01-21
- Results posted
- 2019-11-06
Locations
14 sites across 4 countries: France, Italy, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02733991. Inclusion in this directory is not an endorsement.