Closed-loop Insulin Delivery Systems in Pancreatic Diabetes (IADIASP)

April 5, 2024 updated by: Centre Hospitalier Sud Francilien

Closed-loop Insulin Delivery Systems ("Artificial Pancreas") in Patients With Pancreatitis or Pancreatectomy-induced Diabetes: an Observational Case Series

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").

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Secondary pancreatic diabetes is an unstable diabetes, due to deficiency in B cells which produce insulin, alpha cells which produce glucagon, and exorcrine insufficiency. Patients with secondary pancreatic diabetes are exposed to high glycemic variability and severe hypoglycemic episodes. Hybrid closed loop treatment has shown efficacy and safety for patients with type 1 diabetes and has the potential to improve the control of secondary pancreatic diabetes but has rarely been studied in this particular indication.

A retrospective observational cohort study in patients will be contucted suffering from secondary pancreatic diabetes in whom this device was implemented in order to observe metabolic and safety outcomes compared to the period before they were treated with hybrid closed-loop system.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient who objected to the use of data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group1
Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device
Device: hybrid closed loop insulin delivery system
Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time spent in the target
Time Frame: at day 0
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
Time Frame: at day 90
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time spent
Time Frame: at day 0
Percentage of time spent bellow 70 mg/dL (TBR for Time Bellow Range ) and Above 180 mg/dL (TAR for Time Above Range )
at day 0
Percentage of time spent
Time Frame: at day 90
Percentage of time spent bellow 70 mg/dL (TBR for Time Bellow Range ) and Above 180 mg/dL (TAR for Time Above Range )
at day 90
Pourcentage of closed-loop mode use
Time Frame: at day 90
Pourcentage of closed-loop mode use
at day 90
Hypoglycemia events (serveral hypoglycemia )
Time Frame: at day 0
Number of serveral hypoglycemia events requiring hospitilisation and/or emergency
at day 0
Hypoglycemia events (serveral hypoglycemia )
Time Frame: at day 90
Number of serveral hypoglycemia events requiring hospitilisation and/or emergency
at day 90
Hyperglycemia events
Time Frame: at day 0
Number of hyperglycemia events requiring hospitalisation and /or emergency
at day 0
Hyperglycemia events
Time Frame: at day 90
Number of hyperglycemia events requiring hospitalisation and /or emergency
at day 90
Glucose Management Indicator (GMI)
Time Frame: at day 0
Glucose Management Indicator (GMI)
at day 0
Glucose Management Indicator (GMI)
Time Frame: at day 90
Glucose Management Indicator (GMI)
at day 90
Coeffecient of variabilty of Glucose Management Indicator
Time Frame: at day 0
Coeffecient of variabilty
at day 0
Coeffecient of variabilty of Glucose Management Indicator
Time Frame: at day 90
Coeffecient of variabilty
at day 90
Microangiopathic events
Time Frame: at day 0
Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy )
at day 0
Microangiopathic events
Time Frame: at day 90
Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy )
at day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Alfred PENFORNIS, PHD, Centre Hospitalier Sud Francilien

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2024

Primary Completion (Actual)

April 5, 2024

Study Completion (Actual)

April 5, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/0057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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