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Completed

NCT Number: NCT04915066

Study of Insulin Pump Discontinuation in Adults With Diabetes

The purpose of this study is to determine the rate of insulin pump discontinuation 18 months after initiation in patients with diabetes, and to determine factors associated with this discontinuation.

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Key information

Conditions

Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

About this study

Insulin pump discontinuation has been mostly studied in children and young adults living with diabetes, and rarely with a time-to-event analysis. We aim to evaluate the rate of insulin pump discontinuation after 18 months from initiation and factors associated with it in adults with diabetes.

Knowing these factors would allow better support for patients in difficulty.

Who can participate

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

Inclusion criteria

All patients (adults and adolescents) with diabetes and an insulin pump initiation from 1 January 2015 to 30 June 2018 in the diabetes department of the Centre hospitalier sud francilien.

Exclusion criteria

  • Pregnant women (or women planning pregnancy in the short term) with an insulin pump initiation from 1 January 2015 to 30 June 2018
  • Patients hospitalized for an insulin pump replacement or change between 1 January 2015 and 30 June 2018.
  • Patients with a history of insulin pump initiation within a period of less than 6 months before a new pump start between 1 January 2015 and 30 June 2018.

Treatment and study plan

medical data collection

Other

Collection of medical data from patients'medical records

Primary outcomes

  1. Permanent discontinuation of insulin pump use.

    Time frame: at 18 months

    Insulin pump discontinuation is considered permanent if > 6 consecutive months with patient back to insulin pen and no use of pump-related consumables during the 6 months.

Secondary outcomes

  1. Age

    Time frame: at day 0

    Age of patient at the moment of insulin pump discontinuation.

  2. Sex

    Time frame: at day 0

    Sex of patient

  3. type of diabete

    Time frame: at day 0

    type 1 or 2

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

Probability and Factors Associated With Early Discontinuation of Insulin Pump Therapy in Adults With Diabetes at the Center Hospitalier Sud Francilien

Acronym: STOPPOMPE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2021
Registry last updated
Sep 22, 2021

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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