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

University of Virginia

Status

Withdrawn

Conditions

Type 1 Diabetes

End Stage Renal Disease (ESRD)

Insulin-requiring Type 2 Diabetes Mellitus

Treatments

Device: Artificial Pancreas

Other: Multiple Daily Injections

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04189510

190055

Details and patient eligibility

About

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).

Full 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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥18.0 years old at time of consent
History of insulin requiring diabetes mellitus, type 1 or type 2, who have end stage renal disease (ESRD)
Expected to undergo deceased or living donor kidney transplant surgery
History of insulin prescription (past or current use)
If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study.
Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
Total daily insulin dose (TDD) at least 10 U/day
An understanding and willingness to follow the protocol and signed informed consent

Exclusion criteria

Pregnancy or intent to become pregnant during the trial
Currently breastfeeding or planning to breastfeed
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
Having a family member(s) employed by Tandem Diabetes Care, Inc. or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
Patients who have consented to participate in other interventional trials will be excluded or given the opportunity to exit from the study