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

Primary Purpose

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

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Artificial Pancreas

Multiple Daily Injections

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Type 2 Diabetes, Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Kidney Transplant, Multiple Daily Injections (MDI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artificial Pancreas (AP) Insulin Group

Multiple Daily Injections (MDI) Insulin Group

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04189510

First Posted

November 22, 2019

Last Updated

November 2, 2021

Sponsor

University of Virginia

Collaborators

DexCom, Inc., Tandem Diabetes Care, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04189510

Brief Title

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

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Withdrawn

Why Stopped

ongoing concern of working with high-risk in-hospital transplant population during the various stages of the COVID-19 Pandemic.

Study Start Date

April 1, 2021 (Anticipated)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

Collaborators

DexCom, Inc., Tandem Diabetes Care, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. 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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Artificial Pancreas (AP) Insulin Group

Arm Type

Experimental

Arm Title

Multiple Daily Injections (MDI) Insulin Group

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Artificial Pancreas

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Multiple Daily Injections

Intervention Description

Multiple Daily Injections as standard of care post kidney transplant.

Primary Outcome Measure Information:

Title

Safety of Artificial Pancreas system

Description

Time Frame

5 Weeks

Title

Efficacy of Artificial Pancreas system

Description

Time Frame

5 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meaghan Stumpf, MD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Pending

Learn more about this trial

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

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