Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump

Type I Diabetes Clinical Trial

— AAHPI  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03653533
• Other study ID #: 2017-A01988-45
• Status: Terminated
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: October 18, 2019

Study information

• Verified date: July 2020
• Source: ARAIR Assistance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 18, 2019
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• type I diabetic patients undr basal/prandial diet

• treated by insuline

• with no insuline pump during at least 3 months

• with HbA1C dosed during the 3 months before inclusion

Exclusion Criteria:

• minor patients

• pregnant woman

• already participating to another studies

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type I Diabetes

Intervention

Device:
• MiniMed™ 640G
The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
• Captor CGM Enlite®
The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level
• SmartGuard®
This SmartGuard® function is used to improve the glycemia stability in real condition

Locations

Country	Name	City	State
France	Pole Sante Sud Le Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
ARAIR Assistance

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function	The primary outcome is the area between the glycemic curve and the hypoglycemic level (70 mg/dL), measured between the 6 last days of the phase without SmartGuard® function and the 6 last days with the use of SmartGuard® function	6 days