Trials / Terminated
TerminatedNCT03653533
Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump Coupled With the Continuous Measurement of Interstitial Glycemia in Type 1 Diabetic Adults
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- ARAIR Assistance · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.
Detailed description
The aim of this study is to compare SmartGuard® function with captor and insulin pump to improve the glycemia stability in real condition. There are several phases: * phase 1: insulin pump without captor (12 weeks) * phase 2: insulin pump with captor and without SmartGuard® function (4X6 days; 4 weeks) * phase 3: insulin pump with captor and with SmartGuard® function (6X6 days; 6 weeks) * phase 4: insulin pump without captor (4 weeks)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MiniMed™ 640G | The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin |
| DEVICE | Captor CGM Enlite® | The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level |
| DEVICE | SmartGuard® | This SmartGuard® function is used to improve the glycemia stability in real condition |
Timeline
- Start date
- 2019-01-07
- Primary completion
- 2019-10-18
- Completion
- 2019-10-18
- First posted
- 2018-08-31
- Last updated
- 2020-07-10
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03653533. Inclusion in this directory is not an endorsement.