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Use of Closed Loop Insulin Delivery for Glucose Control in Patients With Insulin Dependent Diabetes Mellitus After Kidney Transplantation

Type 1 Diabetes Clinical Trial

Official title:
Use of Closed Loop Insulin Delivery in the Immediate Postoperative Period Following Deceased Donor Kidney Transplant in Patients With Insulin Dependent Diabetes Mellitus

Clinical Trial Summary

This study will be a prospective, single center, randomized controlled parallel group open-label trial. Participants with insulin requiring diabetes mellitus who have been offered an organ for living or deceased donor kidney transplantation will be recruited prior to transplantation surgery. Patients will be randomized in a 2:1 fashion to AP (6 patients) and conventional treatment groups (3 patients). At the end of the subject's post-operative in-patient stay, participants will have the option of wearing a blinded CGM at home for 4 weeks while treating themselves with multiple daily injections (MDI).

Clinical Trial Description

The purpose of this study is to conduct a hypothesis-generating pilot study to assess the efficacy and safety of the closed loop control in kidney transplant recipients with history of insulin requiring diabetes mellitus in the early postoperative period. This study will be a prospective, single center, randomized controlled parallel group open-label trial. Participants with insulin requiring diabetes mellitus who have been offered an organ for living or deceased donor kidney transplantation will be recruited prior to transplantation surgery. Patients will be randomized in a 2:1 fashion to AP (6 patients) and conventional treatment groups (3 patients). At the end of the subject's post-operative in-patient stay, participants will have the option of wearing a blinded CGM at home for 12 weeks while treating themselves with multiple daily injections (MDI). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04189510
Study type Interventional
Source University of Virginia
Contact
Status Withdrawn
Phase N/A
Start date April 1, 2021
Completion date December 31, 2021
View Details
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