Closed-loop Insulin Delivery Systems in Pancreatic Diabetes

Completed

• Conditions: Secondary Pancreatic Diabetes
• Interventions: Device: hybrid closed loop insulin delivery system

• Registration Number: NCT06227650
• Lead Sponsor: Centre Hospitalier Sud Francilien

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").

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 Timeline

• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-01-29
• Study Start: 2024-02-06
• Status Verified: 2024-04
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Read More

Exclusion Criteria

• Patient who objected to the use of data

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1	hybrid closed loop insulin delivery system	Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device

Primary Outcome Measures

Name	Time	Method
Percentage of time spent in the target	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

Secondary Outcome Measures

Name	Time	Method
Percentage of time spent	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 )
Hyperglycemia events	at day 90	Number of hyperglycemia events requiring hospitalisation and /or emergency
Hypoglycemia events (serveral hypoglycemia )	at day 90	Number of serveral hypoglycemia events requiring hospitilisation and/or emergency
Pourcentage of closed-loop mode use	at day 90	Pourcentage of closed-loop mode use
Glucose Management Indicator (GMI)	at day 90	Glucose Management Indicator (GMI)
Coeffecient of variabilty of Glucose Management Indicator	at day 90	Coeffecient of variabilty
Microangiopathic events	at day 90	Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy )

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, Fra, France