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Trial record 35 of 2357 for:    "Diabetes Mellitus, Insulin-Dependent"

Study the Feasibility of Permanent Use of inControl for the Treatment of Type 1 Diabetes (IDCLTraining)

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ClinicalTrials.gov Identifier: NCT02892604
Recruitment Status : Unknown
Verified November 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : September 8, 2016
Last Update Posted : November 29, 2016
Sponsor:
Collaborators:
MEDBIOMED, Montpellier, France
Jaeb Center for Health Research
University of Virginia
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide scale outpatient trials. Denominated as inControl , it includes improved user interface and communication modules while closed-loop algorithms remain similar. During this pilot study, the investigators will evaluate this new version of AP for a two-week period during which the patients will use it for closed-loop insulin delivery 24/7 The main goal is train the clinical team with the new system and collect patient opinions on system acceptance from questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including 240 patients will be initiated. A total of 5 patients will be included in this training study over a 4-week period.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: insulin pump to inControl AP platform Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Evaluation Study of the Feasibility of a Permanent Use in Free-life of inControl Artificial Pancreas System for the Treatment of Type 1 Diabetes
Study Start Date : November 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: insulin delivery driven by inControl

Closed-loop insulin delivery using inControl AP system is assessed for two weeks, 24/7.

Connection of continuous glucose monitoring (CGM) system and insulin pump to inControl AP platform, all wireless and wearable, in free-life conditions Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.

Device: insulin pump to inControl AP platform
Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.




Primary Outcome Measures :
  1. Percent time of active insulin closed-loop delivery [ Time Frame: 2 weeks ]
    Percent time while AP system is active permanently


Secondary Outcome Measures :
  1. Percent time with blood glucose in target range [ Time Frame: 2 weeks ]
    Percent time while blood glucose is kept in safe 70-180 mg/dl range



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus since more than one year, treated by insulin since at least one year
  • Treatment by insulin pump since at least 6 months
  • Glycated hemoglobin (HbA1c) below 10.5% at inclusion visit
  • For women of child bearing age, no current pregnancy and use of an efficient contraception during the whole research participation
  • Agreement on no use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs, except if this therapy has been used for at least 3 months before study start
  • Agreement on stopping closed-loop insulin delivery after acetaminophen use and 4 following hours
  • Agreement on suspending use of patient CGM device during the study period while study CGM will be used
  • Access to the internet and a mobile phone network at home
  • Agreement on following study procedures
  • Affiliation to the French social security system or a similar healthcare coverage system
  • Mandatory written informed consent

Exclusion Criteria:

  • Need for chronic use of acetaminophen
  • Start of use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs during the 3 months before inclusion
  • Hemophilia or other coagulation disorders
  • Psychological and/or cognitive troubles which may impair the appropriate following of study procedures
  • Diabetic ketoacidosis during the last 6 months
  • Acute cardiovascular event during the last 12 months
  • Severe hypoglycaemia with convulsions or loss of conscience during the last 12 months
  • Use of a therapy with significant impact on glucose metabolism
  • Cystic fibrosis
  • Lack of nearby third-party assistance availability in case of troubles
  • Malignant disease, except if considered as cured since at least 10 years
  • Impaired kidney function (serum creatinin > 150 umol/L)
  • Impaired liver status (ALAT or ASAT > 2-times upper normal limit)
  • Active gastroparesis
  • Acute adrenocortical event
  • Alcohol or narcotics abuse

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): NCT02892604


Contacts
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Contact: Eric M RENARD, MD, PhD 467338382 ext 33 e-renard@chu-montpellier.fr

Locations
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France
UHMontpellier Recruiting
Montpellier, France, 34295
Contact: Eric RENARD, MD PhD    467338382 ext 0033    e-renard@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
MEDBIOMED, Montpellier, France
Jaeb Center for Health Research
University of Virginia
Investigators
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Study Director: Eric M RENARD, MD, PhD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02892604     History of Changes
Other Study ID Numbers: 9722
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Montpellier:
Type 1 diabetes
artificial pancreas
closed-loop insulin infusion

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs