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

Sponsor

University of Virginia (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04189510

Collaborator

DexCom, Inc. (Industry), Tandem Diabetes Care, Inc. (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Insulin-requiring Type 2 Diabetes Mellitus End Stage Renal Disease (ESRD)	Device: Artificial Pancreas Other: Multiple Daily Injections	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artificial Pancreas (AP) Insulin Group	Device: Artificial Pancreas The Artificial Pancreas will delivery insulin in place of Multiple Daily Injections after a kidney transplant.
Active Comparator: Multiple Daily Injections (MDI) Insulin Group	Other: Multiple Daily Injections Multiple Daily Injections as standard of care post kidney transplant.

Arm

Intervention/Treatment

Experimental: Artificial Pancreas (AP) Insulin Group

Device: Artificial Pancreas

The Artificial Pancreas will delivery insulin in place of Multiple Daily Injections after a kidney transplant.

Active Comparator: Multiple Daily Injections (MDI) Insulin Group

Other: Multiple Daily Injections

Multiple Daily Injections as standard of care post kidney transplant.

Outcome Measures

Primary Outcome Measures

Safety of Artificial Pancreas system [5 Weeks]
Safety will be assessed by using a continuous glucose monitor, which measures interstitial glucose concentrations every 5 minutes for 24 hours a day. We will measure percentage of time in 24 hour period that the continuous glucose monitor (CGM) measures interstitial glucose values <70 mg/dL per day as a surrogate assessment of safety.
Efficacy of Artificial Pancreas system [5 Weeks]
Efficacy will be assessed by using a continuous glucose monitor, which measures interstitial glucose concentrations every 5 minutes, 24 hours per day. We will measure percentage of time in 24 hour period that the continuous glucose monitor (CGM) measures interstitial glucose values between 70-180 mg/dL as a surrogate assessment of efficacy.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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