Clinical trial NCT06227650: Closed-loop Insulin Delivery Systems in Pancreatic Diabetes
Official title: Closed-loop Insulin Delivery Systems ("Artificial Pancreas") in Patients With Pancreatitis or Pancreatectomy-induced Diabetes: an Observational Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Pancreatic Diabetes
Keywords: Closed-loop insulin delivery systems
artificial pancreas
pancreatitis
pancreatectomy
secondary diabetes
continuous glucose monitoring
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with secondary pancreatic diabetes and implementation of automated insulin therapy in BF

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patient who objected to the use of data

Primary outcomes:
measure: Percentage of time spent in the target
timeFrame: at day 0
measure: Percentage of time spent in the target
timeFrame: at day 90
Secondary outcomes:
measure: Percentage of time spent
timeFrame: at day 0
measure: Percentage of time spent
timeFrame: at day 90
measure: Pourcentage of closed-loop mode use
timeFrame: at day 90
measure: Hypoglycemia events (serveral hypoglycemia )
timeFrame: at day 0
measure: Hypoglycemia events (serveral hypoglycemia )
timeFrame: at day 90
measure: Hyperglycemia events
timeFrame: at day 0
measure: Hyperglycemia events
timeFrame: at day 90
measure: Glucose Management Indicator (GMI)
timeFrame: at day 0
measure: Glucose Management Indicator (GMI)
timeFrame: at day 90
measure: Coeffecient of variabilty of Glucose Management Indicator
timeFrame: at day 0
measure: Coeffecient of variabilty of Glucose Management Indicator
timeFrame: at day 90
measure: Microangiopathic events
timeFrame: at day 0
measure: Microangiopathic events
timeFrame: at day 90
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
state: Fra
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Alfred PENFORNIS, PHD
role: PRINCIPAL_INVESTIGATOR
References: