NCT04915066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

June 29, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

May 28, 2021

Last Update Submit

September 21, 2021

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus, type 1Diabetes mellitus, type 2Insulin Infusion SystemsPatient Education

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Age

    at day 0

  • Sex

    at day 0

  • type of diabete

    at day 0

Interventions

Medical data collectionOTHER

Collection of medical data from patients'medical records

Eligibility Criteria

Age13 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sample of patients from the diabetes department of a public hospital in France (Corbeil-Essonnes).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2021

First Posted

June 7, 2021

Study Start

June 29, 2021

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)