Study of Insulin Pump Discontinuation in Adults With Diabetes

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT04915066
• Lead Sponsor: Centre Hospitalier Sud Francilien

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-07
• Study Start: 2021-06-29
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 313

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Permanent discontinuation of insulin pump use.	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 Outcome Measures

Name	Time	Method
type of diabete	at day 0	type 1 or 2
Age	at day 0	Age of patient at the moment of insulin pump discontinuation.
Sex	at day 0	Sex of patient

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes Cedex, France