Clinical trial NCT04189510: Use of Closed Loop Insulin Delivery for Glucose Control in Patients With Insulin Dependent Diabetes Mellitus After Kidney Transplantation
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Insulin-requiring Type 2 Diabetes Mellitus
End Stage Renal Disease (ESRD)
Keywords: Type 1 Diabetes
Type 2 Diabetes
Artificial Pancreas (AP)
Continuous Glucose Monitor (CGM)
Kidney Transplant
Multiple Daily Injections (MDI)
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
name: Tandem Diabetes Care, Inc.
First posted: 2019-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: Inclusion Criteria:

1. Age ≥18.0 years old at time of consent
2. History of insulin requiring diabetes mellitus, type 1 or type 2, who have end stage renal disease (ESRD)
3. Expected to undergo deceased or living donor kidney transplant surgery
4. History of insulin prescription (past or current use)
5. 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.
6. 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
7. Total daily insulin dose (TDD) at least 10 U/day
8. An understanding and willingness to follow the protocol and signed informed consent

Exclusion Criteria:

1. Pregnancy or intent to become pregnant during the trial
2. Currently breastfeeding or planning to breastfeed
3. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
4. 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.
5. Patients who have consented to participate in other interventional trials will be excluded or given the opportunity to exit from the study

Primary outcomes:
measure: Safety of Artificial Pancreas system
timeFrame: 5 Weeks
measure: Efficacy of Artificial Pancreas system
timeFrame: 5 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Meaghan Stumpf, MD
role: PRINCIPAL_INVESTIGATOR
References: