Study Stopped
Difficulties for recruitment
Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
AAHPI
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedStudy Start
First participant enrolled
January 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2019
CompletedJuly 10, 2020
July 1, 2020
9 months
June 12, 2018
July 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
MiniMed™ 640G alone
OTHERMiniMed™ 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.
MiniMed™ 640G + Captor CGM Enlite®
OTHERinsulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
MiniMed™ 640G + Captor + SmartGuard®
OTHERinsulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
Interventions
The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level
This SmartGuard® function is used to improve the glycemia stability in real condition
Eligibility Criteria
You may qualify if:
- type I diabetic patients undr basal/prandial diet
- treated by insuline
- with no insuline pump during at least 3 months
You may not qualify if:
- minor patients
- pregnant woman
- already participating to another studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ARAIR Assistancelead
Study Sites (1)
Pole Sante Sud Le Mans
Le Mans, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2018
First Posted
August 31, 2018
Study Start
January 7, 2019
Primary Completion
October 18, 2019
Study Completion
October 18, 2019
Last Updated
July 10, 2020
Record last verified: 2020-07