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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653533
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
ARAIR Assistance

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.

Condition or disease Intervention/treatment Phase
Type I Diabetes Device: MiniMed™ 640G Device: Captor CGM Enlite® Device: SmartGuard® Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
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

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

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653533


Contacts
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Contact: Isabelle Papon 02 47 25 45 00 isabelle.papon@arair.fr

Locations
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France
Pole Sante Sud Le Mans Recruiting
Le Mans, France
Contact: Claire GAUTIER         
Sponsors and Collaborators
ARAIR Assistance

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Responsible Party: ARAIR Assistance
ClinicalTrials.gov Identifier: NCT03653533    
Other Study ID Numbers: 2017-A01988-45
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoglycemia
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs