NCT06227650

Brief Summary

The purpose of this study is to evaluate the metabolic and the safety outcomes in people living with pancreatic diabetes (pancreatitis or pancreatectomy-induced diabetes) and using a closed-loop insulin delivery systems ("artificial pancreas").

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

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

January 17, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 6, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

January 17, 2024

Last Update Submit

April 5, 2024

Conditions

Secondary Pancreatic Diabetes

Keywords

Closed-loop insulin delivery systemsartificial pancreaspancreatitispancreatectomysecondary diabetescontinuous glucose monitoring

Outcome Measures

Primary Outcomes (2)

  • Percentage of time spent in the target

    Percentage of time spent in the target, between 70 and 180 mg/dl: 14 to 90 days before starting hybrid closed loop

    at day 0

  • Percentage of time spent in the target

    Percentage of time spent in the target, between 70 and 180 mg/dl the last 90 days available (T1) after starting hybrid closed loop

    at day 90

Secondary Outcomes (13)

  • Percentage of time spent

    at day 0

  • Percentage of time spent

    at day 90

  • Pourcentage of closed-loop mode use

    at day 90

  • Hypoglycemia events (serveral hypoglycemia )

    at day 0

  • Hypoglycemia events (serveral hypoglycemia )

    at day 90

  • +8 more secondary outcomes

Study Arms (1)

Group1

Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device

Device: hybrid closed loop insulin delivery system

Interventions

hybrid closed loop insulin delivery systemDEVICE

Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device

Group1

Eligibility Criteria

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

Patients with secondary pancreatic diabetes and implementation of automated insulin therapy in BF

You may qualify if:

  • Adult patient
  • Presenting secondary pancreatic diabetes
  • Treatment with insulin closed-loop delivery

You may not qualify if:

  • Patient who objected to the use of data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, Fra, 9110, France

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Alfred PENFORNIS, PHD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 29, 2024

Study Start

February 6, 2024

Primary Completion

April 5, 2024

Study Completion

April 5, 2024

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)