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

Diabetes, Type 1 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657213
• Other study ID #: 38RC15.110
• Status: Completed
• Phase: N/A
• First received: January 6, 2016
• Last updated: October 17, 2017
• Start date: February 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes, Type 1
• Hypoglycemia

Intervention

Device:
• Minimed 640G with smartguard activated
Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation
• Minimed 640G with smartguard off
Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Secondary	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	6 months
Secondary	Assessment of the quality of life of patients with smartguard activation	Quality of Life Questionnaire	6 months
Secondary	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)	6 months
Secondary	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.	6 months