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

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ClinicalTrials.gov Identifier: NCT03494010
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

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.


Condition or disease Intervention/treatment
Diabetes, Type 1 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hybrid Closed-Loop Insulin Delivery System in Type 1 Diabetes Candidates for a Living Donor Kidney Transplant
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Duration of use of hybrid closed-loop (HCL) system [ Time Frame: up to 1 year post-surgery ]
    Use will be measured in weeks


Secondary Outcome Measures :
  1. Kidney transplantation outcome - graft rejection [ Time Frame: Up to 3 months post-transplant ]
  2. Kidney transplantation outcome - infections [ Time Frame: Up to 3 months post-transplant ]
  3. Kidney transplantation outcome - mortality [ Time Frame: 3 years from study enrollment ]
  4. hyperglycemia: glucose levels > 180 milligrams per deciliter (mg/dL) [ Time Frame: change from baseline to 1 month after surgery ]
    Blood samples taken from study subjects will be used to measure this outcome.

  5. hyperglycemia: glucose levels > 180 mg/dL [ Time Frame: change from baseline to 1 year after surgery ]
    Blood samples taken from study subjects will be used to measure this outcome.

  6. hypoglycemia: glucose levels <70 mg/dL [ Time Frame: change from baseline to 1 month after surgery ]
    Blood samples taken from study subjects will be used to measure this outcome.

  7. hypoglycemia: glucose levels <70 mg/dL [ Time Frame: change from baseline to 1 year after surgery ]
    Blood samples taken from study subjects will be used to measure this outcome.

  8. hemoglobin A1c [ Time Frame: change from baseline to 1 month after surgery ]
    Blood samples taken from study subjects will be used to measure this outcome.

  9. hemoglobin A1c [ Time Frame: change from baseline to 1 year after surgery ]
    Blood samples taken from study subjects will be used to measure this outcome.

  10. fasting glucose levels [ Time Frame: change from baseline to 1 month after surgery ]
    Blood samples taken from study subjects will be used to measure this outcome.

  11. fasting glucose levels [ Time Frame: change from baseline to 1 year after surgery ]
    Blood samples taken from study subjects will be used to measure this outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494010


Contacts
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Contact: Renata Belfort De Aguiar, MD, PhD 203 785 2440 renata.aguiar@yale.edu

Locations
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United States, Connecticut
Yale-New Haven Organ Transplant Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Renata Belfort De Aguiar, MD, PhD    203-785-6222    renata.aguiar@yale.edu   
Contact: Ricarda Tomlin    203-785-2073    ricarda.tomlin@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Renata Belfort De Aguiar, MD, PhD Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03494010    
Other Study ID Numbers: 2000022558
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Yale University:
Kidney Transplantation
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases