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Study of Insulin Pump Discontinuation in Adults With Diabetes (STOPPOMPE)

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ClinicalTrials.gov Identifier: NCT04915066
Recruitment Status : Recruiting
First Posted : June 7, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Sud Francilien

Tracking Information
First Submitted Date May 28, 2021
First Posted Date June 7, 2021
Last Update Posted Date June 7, 2021
Estimated Study Start Date June 5, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2021)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 4, 2021)
  • Age [ Time Frame: at day 0 ]
    Age of patient at the moment of insulin pump discontinuation.
  • Sex [ Time Frame: at day 0 ]
    Sex of patient
  • type of diabete [ Time Frame: at day 0 ]
    type 1 or 2
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Insulin Pump Discontinuation in Adults With Diabetes
Official Title Probability and Factors Associated With Early Discontinuation of Insulin Pump Therapy in Adults With Diabetes at the Center 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Sample of patients from the diabetes department of a public hospital in France (Corbeil-Essonnes).
Condition Diabetes Mellitus
Intervention Other: Medical data collection
Collection of medical data from patients'medical records
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 4, 2021)
315
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Alfred PENFORNIS, PHD (33) 1 61 69 75 50 alfred.penfornis@chsf.fr
Contact: Caroline TOURTE GROSPIRON (33) 1 61 69 31 50 caroline.tourte@chsf.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04915066
Other Study ID Numbers 2021/0012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Sud Francilien
Study Sponsor Centre Hospitalier Sud Francilien
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Sud Francilien
Verification Date June 2021