Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-06 @ 10:01 AM
Study NCT ID:
NCT03653533
Status:
TERMINATED
Last Update Posted:
2020-07-10
First Post:
2018-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
Sponsor:
ARAIR Assistance
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties for recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AAHPI
Brief 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)
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)
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: