Peri-transplant insulin therapy in pancreas transplantatio

Not Applicable

• Conditions: Pancreas transplantation for treatment of diabetes mellitus; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN51170824
• Lead Sponsor: The University of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-16
• Last Update Posted: 26 April 2021
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

All patients undergoing simultaneous pancreas and kidney transplantation will be considered eligible for inclusion in the trial. Eligibility for pancreas transplantation is outlined in the NHSBT Organ Donation and Transplantation Pancreas Selection Policy.

Exclusion Criteria

1. Aged <18 years or >65 years
2. Inability to self-consent
3. Pancreas transplant alone after previous kidney or pancreas transplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome for the feasibility study will be patient safety. Safety will primarily be determined by two measures of glycaemic control: a) the number of hypoglycaemic episodes; and, b) time within the target glucose range. Glycaemic control will be measured hourly using two methods, synchronously: capillary blood glucose (as is standard clinical practice), and continuous glucose monitoring (CGM) using the Freestyle Libre Pro device. CGM data will not be available to the clinical team and will only be analysed by the research team retrospectively. Timepoint(s): Peri-transplant (first five days)