Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
NCT ID: NCT03653533
Last Updated: 2020-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2019-01-07
2019-10-18
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MiniMed™ 640G alone
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.
MiniMed™ 640G
The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
MiniMed™ 640G + Captor CGM Enlite®
insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
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
MiniMed™ 640G + Captor + SmartGuard®
insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* treated by insuline
* with no insuline pump during at least 3 months
* with HbA1C dosed during the 3 months before inclusion
Exclusion Criteria
* pregnant woman
* already participating to another studies
18 Years
ALL
No
Sponsors
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ARAIR Assistance
OTHER
Responsible Party
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Locations
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Pole Sante Sud Le Mans
Le Mans, , France
Countries
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Other Identifiers
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2017-A01988-45
Identifier Type: -
Identifier Source: org_study_id
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