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Completed

NCT Number: NCT02657213

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

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

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Key information

Conditions

Diabetes, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble University Hospital, Grenoble, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimed 640G with smartguard activated

Device

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

Other names: Minimed 640G insulin Pump with Smartguard activation

Minimed 640G with smartguard off

Device

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

Other names: Minimed 640G insulin Pump without activated Smartguard

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: ALPPHY

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2016
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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