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Withdrawn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
Sponsored by
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
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
No
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
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.
Time Frame
5 Weeks
Title
Efficacy of Artificial Pancreas system
Description
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.
Time Frame
5 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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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