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Closed-loop Insulin Delivery Systems in Pancreatic Diabetes

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06227650
Acronym
IADIASP
Enrollment
10
Registered
2024-01-29
Start date
2024-02-06
Completion date
2024-04-05
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Pancreatic Diabetes

Keywords

Closed-loop insulin delivery systems, artificial pancreas, pancreatitis, pancreatectomy, secondary diabetes, continuous glucose monitoring

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.

Interventions

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

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patient who objected to the use of data

Design outcomes

Primary

MeasureTime frameDescription
Percentage of time spent in the targetat day 0Percentage of time spent in the target, between 70 and 180 mg/dl: 14 to 90 days before starting hybrid closed loop

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026