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

July 9, 2020 updated by: ARAIR Assistance

Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump Coupled With the Continuous Measurement of Interstitial Glycemia in Type 1 Diabetic Adults

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Mans, France
        • Pole Sante Sud Le Mans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
Device: MiniMed™ 640G
The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
OTHER: 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.
Device: MiniMed™ 640G
The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
Device: Captor CGM Enlite®
The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level
OTHER: MiniMed™ 640G + Captor + SmartGuard®
insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
Device: MiniMed™ 640G
The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
Device: Captor CGM Enlite®
The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level
Device: SmartGuard®
This SmartGuard® function is used to improve the glycemia stability in real condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function
Time Frame: 6 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARAIR Assistance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 7, 2019

Primary Completion (ACTUAL)

October 18, 2019

Study Completion (ACTUAL)

October 18, 2019

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (ACTUAL)

August 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A01988-45

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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