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Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia (ALPPHY)

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ClinicalTrials.gov Identifier: NCT02657213
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1 diabetic adults with an increased risk of hypoglycemia.

The study should show:

  • A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a reduction in the time spent in hypoglycemia six months in any group compared to Baseline.
  • A complete prevention of severe and not severe hypoglycemia in the pump group Minimed 640G + Enlite sensor with SmartGuard activation

Condition or disease Intervention/treatment Phase
Diabetes, Type 1 Device: Minimed 640G with smartguard activated Device: Minimed 640G with smartguard off Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Minimed 640G Insulin Pump With SmartGuard in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia
Actual Study Start Date : February 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minimed 640G with smartguard activated
Group "SmartGuard On": Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640G insulin pump with SmartGuard activation
Device: Minimed 640G with smartguard activated
Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation
Other Name: Minimed 640G insulin Pump with Smartguard activation

Active Comparator: Minimed 640G with smartguard off
Group "SmartGuard Off" Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640 insulin pump without SmartGuard activation
Device: Minimed 640G with smartguard off
Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation
Other Name: Minimed 640G insulin Pump without activated Smartguard




Primary Outcome Measures :
  1. Assessment of the Minimed 640G insulin pump with Smartguard activation in preventing the number of severe and non-severe hypoglycaemia in patients with diabetes type 1 at risk of severe hypoglycemia [ Time Frame: 6 months ]
    Number of events of hypoglycemia (severe and non-severe)


Secondary Outcome Measures :
  1. Assessment of Improving of overall glycemic control with SmartGuard activation in type 1 diabetic patients at risk of severe hypoglycemia [ Time Frame: 6 months ]
    Comprehensive metabolic evaluation data and evaluation data of severe hypoglycaemic risk

  2. Assessment of the quality of life of patients with smartguard activation [ Time Frame: 6 months ]
    Quality of Life Questionnaire

  3. Assessment of the number of adverse events [ Time Frame: 6 months ]
    Assessment of the safety of the sensor augmented pump therapy with the Mimimed 640G insulin pump coupled with a 640G Minimed Enlite sensor with Smart Guard as compare to sensor augmented pump therapy with the Mimimed 640G insulin pump coupled with a 640G Minimed Enlite sensor without Smart Guard activation (Decompensated ketoacidosis, Hospitalization related to severe hypoglycemia or frequent hypoglycemia or moderate decompensation, Materiovigilance data, Collection and monitoring of serious adverse events and non-serious)

  4. Study of average cost per patient for each therapeutic strategy supported from the point of view of society [ Time Frame: 6 months ]
    An average cost per patient will be calculated for each strategy. The horizon time is 6 months from randomization of the patient.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or insulin-dependent diabetic patients
  • Patients treated with subcutaneous insulin pump with at least 2 episodes of severe hypoglycemia within 12 months before the study enrollment
  • Affiliation to the french social security system or equivalent
  • People who signed the consent form

Exclusion Criteria:

  • Patient who have difficulty to understand the French language
  • Patient can not be raised to the use of an insulin pump, or a glucose sensor
  • Patient visually impaired
  • Patient hard of hearing
  • Pregnant woman or woman having a project of pregnancy within 6 months
  • Persons referred to in Articles L1121-5 to L1121-8 CSP: pregnant woman, woman in labor, breastfeeding women, persons deprived of their liberty by judicial or administrative decision, person under a legal protection measure.

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): NCT02657213


Locations
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France
Grenoble University Hospital
Grenoble, France, 38000
Montpellier University Hospital
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Sandrine LABLANCHE, MD University Hospital, Grenoble

Publications:
European User Evaluation of the MiniMed® 640G system. Poster session at the American Diabetes Association (ADA) 75th Scientific Sessions on Sunday, June 7 2015. Boston Convention and Exhibition Center.

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02657213     History of Changes
Other Study ID Numbers: 38RC15.110
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Grenoble:
Diabetes, Type 1
Hypoglycemia
Insulin Infusion Systems

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