Hybrid Closed-Loop Insulin Delivery System in Type 1 Diabetes Candidates for a Living Donor Kidney Transplant

NCT03494010 | Withdrawn FDA Device

• 1 other identifier: 2000022558
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' primary aim is to determine the impact of using hybrid closed-loop (HCL) system in patients with type 1 diabetes (T1D) and end stage renal disease (ESRD) prior to kidney transplantation. The investigators will also determine whether HCL, by improving glucose control, will affect short-term (1 month) and long-term (12 months) complications after kidney transplantation in patients with T1D.

Conditions

Diabetes, Type 1

Keywords

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Duration of use of hybrid closed-loop (HCL) system

  Use will be measured in weeks

  up to 1 year post-surgery

Secondary Outcomes (11)

• Kidney transplantation outcome - graft rejection

  Up to 3 months post-transplant

• Kidney transplantation outcome - infections

  Up to 3 months post-transplant

• Kidney transplantation outcome - mortality

  3 years from study enrollment

• hyperglycemia: glucose levels > 180 milligrams per deciliter (mg/dL)

  change from baseline to 1 month after surgery

• hyperglycemia: glucose levels > 180 mg/dL

  change from baseline to 1 year after surgery

Study Arms (2)

prospective cohort

Patients will be followed to determine the impact of the hybrid closed-loop (HCL) system that was prescribed at part of clinical care.

Other: Observation

historical controls

Medical record data of these patients, who did not use the HCL system, will be compared with patients in the HCL cohort.

Interventions

Observation OTHER

There is no intervention. Patients will receive the HCL system as part of their clinical care.

prospective cohort

Eligibility Criteria

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

Study Population

Patients with type 1 diabetes who have had (historical controls) or who plan to have (cohort) a living donor kidney transplant at Yale New haven Hospital.

You may qualify if:

• Type 1 diabetes
• Recipient of (historical controls) or on waiting list for (cohort) a living donor kidney transplant.

You may not qualify if:

• Cohort and Historical Controls:
• Vision, hearing impairment (patients cannot recognize the pump and sensor signals and alarms)
• Cognitive impairment (unless 24-hour caregiver is available)
• Total daily insulin dose requirements less than 8 units per day
• Patients who are not willing to check their blood glucose test at least twice a day
• Not followed/do not plan be followed at Yale New Haven Hospital
• Cohort:
• No living donor candidate

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale-New Haven Organ Transplant Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Renata Belfort De Aguiar, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 11, 2018
• Study Start: August 31, 2018
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)