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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

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.

Condition or disease Intervention/treatment
Diabetes Mellitus Other: Medical data collection

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.

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Study Type : Observational
Estimated Enrollment : 315 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Probability and Factors Associated With Early Discontinuation of Insulin Pump Therapy in Adults With Diabetes at the Center Hospitalier Sud Francilien
Estimated Study Start Date : June 5, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : October 1, 2021

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


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Sample of patients from the diabetes department of a public hospital in France (Corbeil-Essonnes).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04915066


Contacts
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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

Locations
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France
Centre Hospitalier Sud Francilien Recruiting
Corbeil-essonnes Cedex, France, 91106
Contact: Alfred PENFORNIS    (33) 1 61 69 75 50    alfred.penfornis@chsf.fr   
Principal Investigator: Coralie AMADOU, MD         
Sponsors and Collaborators
Centre Hospitalier Sud Francilien
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Responsible Party: Centre Hospitalier Sud Francilien
ClinicalTrials.gov Identifier: NCT04915066    
Other Study ID Numbers: 2021/0012
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Sud Francilien:
Diabetes mellitus, type 1
Diabetes mellitus, type 2
Insulin Infusion Systems
Patient Education
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases