Back to resultsEvaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump (AAHPI)
Primary Purpose
Type I Diabetes
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MiniMed™ 640G
Captor CGM Enlite®
SmartGuard®
Sponsored by
About this trial
This is an interventional treatment trial for Type I Diabetes
Eligibility Criteria
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
Sites / Locations
- Pole Sante Sud Le Mans
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
MiniMed™ 640G alone
MiniMed™ 640G + Captor CGM Enlite®
MiniMed™ 640G + Captor + SmartGuard®
Arm Description
MiniMed™ 640G (insulin pump) is used without Captor CGM Enlite® (captor) at phase 1 and phase 4 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03653533
Brief Title
Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficulties for recruitment
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARAIR Assistance
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MiniMed™ 640G alone
Arm Type
Other
Arm Description
MiniMed™ 640G (insulin pump) is used without Captor CGM Enlite® (captor) at phase 1 and phase 4 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
Arm Title
MiniMed™ 640G + Captor CGM Enlite®
Arm Type
Other
Arm Description
insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
Arm Title
MiniMed™ 640G + Captor + SmartGuard®
Arm Type
Other
Arm Description
insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
Intervention Type
Device
Intervention Name(s)
MiniMed™ 640G
Intervention Description
The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
Intervention Type
Device
Intervention Name(s)
Captor CGM Enlite®
Intervention Description
The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level
Intervention Type
Device
Intervention Name(s)
SmartGuard®
Intervention Description
This SmartGuard® function is used to improve the glycemia stability in real condition
Primary Outcome Measure Information:
Title
Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function
Description
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
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pole Sante Sud Le Mans
City
Le Mans
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
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