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

Study Overview
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Brief Summary
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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
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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).

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

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

Intervention / Treatment
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* Device: Artificial Pancreas
* Other: Multiple Daily Injections


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Artificial Pancreas system | 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. | 5 Weeks | 
| Efficacy of Artificial Pancreas system | 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. | 5 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Type 2 Diabetes, Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Kidney Transplant, Multiple Daily Injections (MDI)