MedTrace Logo

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

NCT04189510 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-11-10

No results posted yet for this study

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)

Interventions

DEVICE

Artificial Pancreas

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

OTHER

Multiple Daily Injections

Multiple Daily Injections as standard of care post kidney transplant.

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Tandem Diabetes Care, Inc.

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Meaghan Stumpf, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Device
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04189510 on ClinicalTrials.gov