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

NCT ID: NCT04189510

Last Updated: 2021-11-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2021-12-31

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).

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artificial Pancreas (AP) Insulin Group

Group Type: EXPERIMENTAL

Artificial Pancreas

Intervention Type: DEVICE

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

Multiple Daily Injections (MDI) Insulin Group

Group Type: ACTIVE_COMPARATOR

Multiple Daily Injections

Intervention Type: OTHER

Multiple Daily Injections as standard of care post kidney transplant.

Interventions

Artificial Pancreas

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

Intervention Type: DEVICE

Multiple Daily Injections

Multiple Daily Injections as standard of care post kidney transplant.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Meaghan Stumpf, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meaghan Stumpf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Countries

United States

Other Identifiers

190055

Identifier Type: -

Identifier Source: org_study_id