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NCT04915066 Clinical Trial

Study of Insulin Pump Discontinuation in Adults With Diabetes

Diabetes Mellitus Clinical Trial

— STOPPOMPE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04915066
Other study ID # 2021/0012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 29, 2021
Est. completion date July 30, 2021

Study information
Verified date September 2021
Source Centre Hospitalier Sud Francilien
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 313
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers
Gender All
Age group 13 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Medical data collection
Collection of medical data from patients'medical records

Locations
Country Name City State
France Centre Hospitalier Sud Francilien Corbeil-essonnes Cedex

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Permanent discontinuation of insulin pump use. 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. at 18 months
Secondary Age Age of patient at the moment of insulin pump discontinuation. at day 0
Secondary Sex Sex of patient at day 0
Secondary type of diabete type 1 or 2 at day 0
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