NCT05282264

Brief Summary

While closed-loop insulin delivery (CLID) systems demonstrated safety and effectiveness in patients with unbalanced type 1 diabetes (T1D), no studies have included patients with highly and chronically unbalanced diabetes. The investigators conduct a retrospective, observational, and single-center study to evaluate the acceptability, safety, and efficacy of a CLID system in patients living with T1D (≥2 years) with a HbA1c\>11% in the past 12 months and a mean HbA1c \>10% over the past three years. Efficacy was assessed using continuous glucose monitoring parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

2 active sites

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

February 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

December 21, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

February 4, 2022

Last Update Submit

December 20, 2023

Conditions

Type 1 Diabetes

Keywords

Highly unbalanced Type 1 diabeteshybrid closed loopsacceptabilityefficacy and safetyquality of life

Outcome Measures

Primary Outcomes (1)

  • Acceptability of hybrid closed-loop systems

    Maintenance rate of a hybrid closed-loop system in patients living with highly unbalanced T1D (HbA1c \> 11%) and followed in the diabetes department of the CHSF

    at 12 months

Secondary Outcomes (10)

  • Demographic characteristics : age

    at day 0

  • Demographic characteristics : gender

    at day 0

  • Demographic characteristics : level of education

    at day 0

  • Demographic characteristics : currrent activity

    at day 0

  • Demographic characteristics : duration of diabete

    at day 0

  • +5 more secondary outcomes

Study Arms (2)

Patient with hybrid closed-loop systems

Other: device

Patient without hybrid closed-loop systems

Interventions

deviceOTHER

closed-loop insulin

Patient with hybrid closed-loop systems

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients followed in the diabetes department of the Centre Hospitalier Sud Francilien

You may qualify if:

  • Patients with closed loop system :
  • Adult patients
  • With T1D for at least 2 years
  • Follow-up in the diabetes department of the CHSF
  • Having a laboratory HbA1c \> 11% at least once during the past year and at least one other HbA1c \> 10% in the previous 3 years
  • Accepting the closed loop system as part of their support
  • Subject informed of the study and not objecting to it
  • Patients without closed loop system :
  • Adult patients
  • With T1D for at least 2 years
  • Follow-up in the diabetes department of the CHSF
  • Having a laboratory HbA1c \> 11% at least once during the past year and at least one other HbA1c \> 10% in the previous 3 years
  • Refusing the closed loop system as part of their support or
  • Patients for whom a multi-professional medical and paramedical collegial discussion (including diabetologist and nurse referents of the patient) within the service leads to the evaluation of an unfavorable benefit/risk ratio
  • Subject informed of the study and not objecting to it

You may not qualify if:

  • Patients with closed loop system :
  • Patients without an Internet connection, or without a smartphone or computer
  • Patients for whom a multi-professional medical and paramedical collegial discussion (including diabetologist and patient referent nurse) within the department results in the assessment of an unfavorable benefit/risk ratio (patients with a history of interrupted pump treatment on medical decision, serious psychiatric disorders…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Penfornis

Corbeil-Essonnes, Centre Hospitalier Sud Francilien, 91106, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

Related Publications (1)

  • Deepchand S, Balla V, Eroukhmanoff J, Ly Sall K, Romain B, Lejeune M, Penfornis A, Amadou C. Closed-Loop Insulin Delivery Systems for People with Type 1 Diabetes and Chronic Very Poor Metabolic Control: It Works and Is Safe! Diabetes Technol Ther. 2024 Feb;26(2):125-129. doi: 10.1089/dia.2023.0379. Epub 2024 Jan 11.

    PMID: 37955849DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

February 4, 2022

First Posted

March 16, 2022

Study Start

April 1, 2022

Primary Completion

July 15, 2023

Study Completion

December 11, 2023

Last Updated

December 21, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)