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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)

Primary Purpose

Diabetes, Type 1

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Minimed 640G with smartguard activated
Minimed 640G with smartguard off
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes, Type 1 focused on measuring Diabetes, Type 1, Hypoglycemia, Insulin Infusion Systems

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grenoble University Hospital
  • Montpellier University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minimed 640G with smartguard activated

Minimed 640G with smartguard off

Arm Description

Group "SmartGuard On": Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640G insulin pump with SmartGuard activation

Group "SmartGuard Off" Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640 insulin pump without SmartGuard activation

Outcomes

Primary Outcome Measures

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
Number of events of hypoglycemia (severe and non-severe)

Secondary Outcome Measures

Assessment of Improving of overall glycemic control with SmartGuard activation in type 1 diabetic patients at risk of severe hypoglycemia
Comprehensive metabolic evaluation data and evaluation data of severe hypoglycaemic risk
Assessment of the quality of life of patients with smartguard activation
Quality of Life Questionnaire
Assessment of the number of adverse events
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)
Study of average cost per patient for each therapeutic strategy supported from the point of view of society
An average cost per patient will be calculated for each strategy. The horizon time is 6 months from randomization of the patient.

Full Information

First Posted
January 6, 2016
Last Updated
October 17, 2017
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02657213
Brief Title
Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia
Acronym
ALPPHY
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Type 1
Keywords
Diabetes, Type 1, Hypoglycemia, Insulin Infusion Systems

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimed 640G with smartguard activated
Arm Type
Experimental
Arm Description
Group "SmartGuard On": Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640G insulin pump with SmartGuard activation
Arm Title
Minimed 640G with smartguard off
Arm Type
Active Comparator
Arm Description
Group "SmartGuard Off" Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640 insulin pump without SmartGuard activation
Intervention Type
Device
Intervention Name(s)
Minimed 640G with smartguard activated
Other Intervention Name(s)
Minimed 640G insulin Pump with Smartguard activation
Intervention Description
Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation
Intervention Type
Device
Intervention Name(s)
Minimed 640G with smartguard off
Other Intervention Name(s)
Minimed 640G insulin Pump without activated Smartguard
Intervention Description
Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation
Primary Outcome Measure Information:
Title
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
Description
Number of events of hypoglycemia (severe and non-severe)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assessment of Improving of overall glycemic control with SmartGuard activation in type 1 diabetic patients at risk of severe hypoglycemia
Description
Comprehensive metabolic evaluation data and evaluation data of severe hypoglycaemic risk
Time Frame
6 months
Title
Assessment of the quality of life of patients with smartguard activation
Description
Quality of Life Questionnaire
Time Frame
6 months
Title
Assessment of the number of adverse events
Description
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)
Time Frame
6 months
Title
Study of average cost per patient for each therapeutic strategy supported from the point of view of society
Description
An average cost per patient will be calculated for each strategy. The horizon time is 6 months from randomization of the patient.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandrine LABLANCHE, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23789889
Citation
Bergenstal RM, Klonoff DC, Garg SK, Bode BW, Meredith M, Slover RH, Ahmann AJ, Welsh JB, Lee SW, Kaufman FR; ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med. 2013 Jul 18;369(3):224-32. doi: 10.1056/NEJMoa1303576. Epub 2013 Jun 22.
Results Reference
background
Citation
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.
Results Reference
background

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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

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