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

NCT04189510 | Withdrawn FDA Device

• 1 other identifier: 190055
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

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)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Artificial Pancreas (AP) Insulin Group

EXPERIMENTAL

Device: Artificial Pancreas

Multiple Daily Injections (MDI) Insulin Group

ACTIVE COMPARATOR

Other: Multiple Daily Injections

Interventions

Artificial Pancreas DEVICE

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

Artificial Pancreas (AP) Insulin Group

Multiple Daily Injections OTHER

Multiple Daily Injections as standard of care post kidney transplant.

Multiple Daily Injections (MDI) Insulin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• DexCom, Inc.: collaborator
• Tandem Diabetes Care, Inc.: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Kidney Failure, Chronic; Diabetes Mellitus, Type 2

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Study Officials

• Meaghan Stumpf, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: December 6, 2019
• Study Start: April 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11