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NCT Number: NCT06227650

Closed-loop Insulin Delivery Systems in Pancreatic Diabetes

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").

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Key information

Conditions

Secondary Pancreatic Diabetes Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, Fra, 9110, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient who objected to the use of data

Treatment and study plan

Hybrid closed loop insulin delivery system

Device

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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 )

  2. 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 )

  3. Pourcentage of closed-loop mode use

    Time frame: at day 90

    Pourcentage of closed-loop mode use

  4. Hypoglycemia events (serveral hypoglycemia )

    Time frame: at day 0

    Number of serveral hypoglycemia events requiring hospitilisation and/or emergency

  5. Hypoglycemia events (serveral hypoglycemia )

    Time frame: at day 90

    Number of serveral hypoglycemia events requiring hospitilisation and/or emergency

  6. Hyperglycemia events

    Time frame: at day 0

    Number of hyperglycemia events requiring hospitalisation and /or emergency

  7. Hyperglycemia events

    Time frame: at day 90

    Number of hyperglycemia events requiring hospitalisation and /or emergency

  8. Glucose Management Indicator (GMI)

    Time frame: at day 0

    Glucose Management Indicator (GMI)

  9. Glucose Management Indicator (GMI)

    Time frame: at day 90

    Glucose Management Indicator (GMI)

  10. Coeffecient of variabilty of Glucose Management Indicator

    Time frame: at day 0

    Coeffecient of variabilty

  11. Coeffecient of variabilty of Glucose Management Indicator

    Time frame: at day 90

    Coeffecient of variabilty

  12. Microangiopathic events

    Time frame: at day 0

    Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy )

  13. Microangiopathic events

    Time frame: at day 90

    Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy )

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

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

Acronym: IADIASP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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