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

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

Sponsors

Lead Sponsor: University Hospital, Grenoble

Source 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

Overall Status Completed
Start Date February 2016
Completion Date June 2017
Primary Completion Date June 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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 6 months
Secondary Outcome
Measure Time Frame
Assessment of Improving of overall glycemic control with SmartGuard activation in type 1 diabetic patients at risk of severe hypoglycemia 6 months
Assessment of the quality of life of patients with smartguard activation 6 months
Assessment of the number of adverse events 6 months
Study of average cost per patient for each therapeutic strategy supported from the point of view of society 6 months
Enrollment 20
Condition
Intervention

Intervention Type: Device

Intervention Name: Minimed 640G with smartguard activated

Description: Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation

Arm Group Label: Minimed 640G with smartguard activated

Other Name: Minimed 640G insulin Pump with Smartguard activation

Intervention Type: Device

Intervention Name: Minimed 640G with smartguard off

Description: Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation

Arm Group Label: Minimed 640G with smartguard off

Other Name: Minimed 640G insulin Pump without activated Smartguard

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Sandrine LABLANCHE, MD Principal Investigator University Hospital, Grenoble
Location
Facility:
Grenoble University Hospital | Grenoble, 38000, France
Montpellier University Hospital | Montpellier, 34000, France
Location Countries

France

Verification Date

October 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Minimed 640G with smartguard activated

Type: Experimental

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

Label: Minimed 640G with smartguard off

Type: Active Comparator

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

Acronym ALPPHY
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov