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Completed

NCT Number: NCT02097316

Feasibility Study of the JewelPump Version 3

The study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. Patients will be randomized into 2 groups According to the order of the randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of treatment with their usual pumps.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Marseille-Hôpital Nord, Marseille, France

Loading trial locations.

About this study

The JewelPump (Debiotech) will be compared to the conventional pumps. Patients will treated with the JewelPump during 5 days, and with their usual pump during 5 other days.

The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Strasbourg, and CHRU of Marseille.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients type 1 diabetics treated by external insulin pump;
  • Patients with HbA1c < 8.5%
  • Patients who signed consent

Exclusion criteria

  • Patients type 2 diabetics
  • Patients who have all serious diseases that could interfere with the study

Treatment and study plan

JewelPump

Device

usual insulin pump

Device

Primary outcomes

  1. Time spent in glycemic area 70-180 mg / dl, measured continuously for 5 days with a continuous glucose monitoring (CGM) DEXCOM G4

    Time frame: up to 5 days of each treatment period

    Evaluate the non-inferiority of JewelPump compared to the usual pump patient, on glycemic control.

Secondary outcomes

  1. Time spent in the strict glycemic area 80-140 mg / dl

    Time frame: up to 5 days of each treatment period

    Evaluate the superiority of JewelPump versus usual pump;

Other outcomes

  1. Time spent below 70 mg / dl

    Time frame: up to 5 days in each treatment period

  2. Time spent above 180mg/dl;

    Time frame: up to 5 days in each treatment period

Sponsors and collaborators

Lead sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 27, 2014
Registry last updated
Oct 27, 2014

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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