NCT04189510

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Type 1 Diabetes
• Insulin-requiring Type 2 Diabetes Mellitus
• End Stage Renal Disease (ESRD)

Interventions

Type	Name	Description
DEVICE	Artificial Pancreas	The Artificial Pancreas will delivery insulin in place of Multiple Daily Injections after a kidney transplant.
OTHER	Multiple Daily Injections	Multiple Daily Injections as standard of care post kidney transplant.

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-12-06
• Last updated: 2021-11-10

Regulatory

• FDA-regulated device study