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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes, Type 1
• Intervention / Treatment: Other: Observation

Detailed Description

The investigators plan to recruit up to 25 patients with type 1 diabetes (T1D) being evaluated for a living donor kidney transplantation. These patients will be followed up to 1 year after the surgery. Participants will be recruited from the Yale Transplantation Center. Patients with end stage renal disease (ESRD) and T1D referred to the pre-transplantation clinic who have a living kidney donor and who are being considered candidates for a hybrid closed-loop (HCL) system as part of routine care, will be asked to participate in this study. Patients who show interest in the HCL system are already being referred to the Yale Transplant-Endocrine Clinic and/or the Yale Diabetes Center to be evaluated for feasibility of using the HCL. Patients will also be approached about the study, once prescribed the HCL 670G system, to be used until the surgery, as standard of care (SOC).

The HCL system will be prescribed as part of a standard care for patients with T1D willing to optimize their glucose control prior to surgery. The HCL system will not be provided by the research investigators. Also as part of SOC, Medtronic® will provide initial training (1st month) and technical support for the patients. Plan for routine care use: The HCL system will be removed during the hospital admission for the transplantation surgery and restarted after hospital discharge. Participants will be followed at the Yale Diabetes Center (YDC) and/or the Yale Transplant-Endocrine Clinic (YTEC) for management of diabetes and management of HCL system.

Patients will be seen monthly prior to the kidney transplantation. After the surgery, they will come to the YDC/YTEC clinics monthly for the first 3 months and every 3 months afterwards.

Patient information to be collected as part of the study:

1. Demographics
2. Blood glucose control test results: hemoglobin A1c, fasting glucose levels
3. Other blood and urine test results pertinent to the protocol, such as: complete blood count (CBC), chemistry, kidney and liver function tests, glomerular filtration rate (GFR), urinary protein/albumin
4. HCL system and continuous glucose monitoring (CGM) report: average glucose, standard deviation (SD), indices of glucose variability (coefficient of variation), in target glucose levels, auto-mode, frequency of hypo and hyperglycemia, insulin dose and duration of use
5. Hospitalizations: peri- and post-op hyperglycemia, hypoglycemia, infections, graft rejection, other complications/morbidity, length of stay, readmissions, mortality

The results from this cohort of patients with T1D treated with the HCL undergoing kidney transplantation will be compared to a retrospective cohort of up to 25 patients. This control cohort will be identified through a Joint Data Analytics Team (JDAT) query of patients followed at the Yale Transplant Center aged between 18-65 year, with T1D and who had received a living donor kidney transplantation in the last 3 years prior to the start date of this protocol. Medical records from these patients will be reviewed by the PI and/or co-investigators. Pertinent demographic and medical information will be recorded, as described above for the HCL treated group.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale-New Haven Organ Transplant Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; There is no intervention. Patients will receive the HCL system as part of their clinical care.
historical controls; Medical record data of these patients, who did not use the HCL system, will be compared with patients in the HCL cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of use of hybrid closed-loop (HCL) system	Use will be measured in weeks	up to 1 year post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Blood samples taken from study subjects will be used to measure this outcome.	change from baseline to 1 month after surgery
hyperglycemia: glucose levels > 180 mg/dL	Blood samples taken from study subjects will be used to measure this outcome.	change from baseline to 1 year after surgery
hypoglycemia: glucose levels <70 mg/dL	Blood samples taken from study subjects will be used to measure this outcome.	change from baseline to 1 month after surgery
hypoglycemia: glucose levels <70 mg/dL	Blood samples taken from study subjects will be used to measure this outcome.	change from baseline to 1 year after surgery
hemoglobin A1c	Blood samples taken from study subjects will be used to measure this outcome.	change from baseline to 1 month after surgery
hemoglobin A1c	Blood samples taken from study subjects will be used to measure this outcome.	change from baseline to 1 year after surgery
fasting glucose levels	Blood samples taken from study subjects will be used to measure this outcome.	change from baseline to 1 month after surgery
fasting glucose levels	Blood samples taken from study subjects will be used to measure this outcome.	change from baseline to 1 year after surgery

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Renata Belfort De Aguiar, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2018
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Kidney Transplantation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2000022558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes