Diabetes, Type 1NCT03494010
Hybrid Closed-Loop Insulin Delivery System in Type 1 Diabetes Candidates for a Living Donor Kidney Transplant
An observational study of Diabetes, Type 1, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes, Type 1
- What is being tested?
- Observation
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Type 1 diabetes
- Recipient of (historical controls) or on waiting list for (cohort) a living donor kidney transplant.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Organ Transplant Center
New Haven, Connecticut, 06519
About this study
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.
Read the 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:
- Demographics
- Blood glucose control test results: hemoglobin A1c, fasting glucose levels
- 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
- 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
- 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.
- Conditions
- Diabetes, Type 1
- Being tested
- Observation
- Keywords
- Kidney Transplantation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
There is no intervention. Patients will receive the HCL system as part of their clinical care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of use of hybrid closed-loop (HCL) system
Use will be measured in weeks
Measured: up to 1 year post-surgery
Secondary outcomes (11)
Kidney transplantation outcome - graft rejection
Measured: Up to 3 months post-transplant
Kidney transplantation outcome - infections
Measured: Up to 3 months post-transplant
Kidney transplantation outcome - mortality
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline to 1 year after surgery
hemoglobin A1c
Blood samples taken from study subjects will be used to measure this outcome.
Measured: change from baseline to 1 month after surgery
hemoglobin A1c
Blood samples taken from study subjects will be used to measure this outcome.
Measured: change from baseline to 1 year after surgery
fasting glucose levels
Blood samples taken from study subjects will be used to measure this outcome.
Measured: change from baseline to 1 month after surgery
fasting glucose levels
Blood samples taken from study subjects will be used to measure this outcome.
Measured: change from baseline to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start31 Aug 2018 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Why it stopped: PI was unable to enroll anyone.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Type 1Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renata Belfort De Aguiar, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494010
- Sponsor's protocol ID
- 2000022558
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2018
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Closed-Loop Insulin Delivery System in Type 1 Diabetes Candidates for a Living Donor Kidney Transplant
- ClinicalTrials.gov ID
- NCT03494010
- Acronym / sponsor ID
- 2000022558
- Conditions
- Diabetes, Type 1
- Keywords
- Kidney Transplantation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI was unable to enroll anyone.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 31 Aug 2018 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Demographics
- Blood glucose control test results: hemoglobin A1c, fasting glucose levels
- 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
- 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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prospective cohort | – | Other: ObservationPatients will be followed to determine the impact of the hybrid closed-loop (HCL) system that was prescribed at part of 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Type 1 diabetes
- Recipient of (historical controls) or on waiting list for (cohort) a living donor kidney transplant.
Key exclusion criteria (8 listed)
- Cohort and Historical Controls:
- Cohort:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationThere is no intervention. Patients will receive the HCL system as part of their clinical care. | Other | prospective cohort |
Primary outcome
Duration of use of hybrid closed-loop (HCL) system
Time frame: up to 1 year post-surgery
Use will be measured in weeks
11 secondary outcomes
Kidney transplantation outcome - graft rejection
Time frame: Up to 3 months post-transplant
Kidney transplantation outcome - infections
Time frame: Up to 3 months post-transplant
Kidney transplantation outcome - mortality
Time frame: 3 years from study enrollment
hyperglycemia: glucose levels > 180 milligrams per deciliter (mg/dL)
Time frame: change from baseline to 1 month after surgery
hyperglycemia: glucose levels > 180 mg/dL
Time frame: change from baseline to 1 year after surgery
hypoglycemia: glucose levels <70 mg/dL
Time frame: change from baseline to 1 month after surgery
hypoglycemia: glucose levels <70 mg/dL
Time frame: change from baseline to 1 year after surgery
hemoglobin A1c
Time frame: change from baseline to 1 month after surgery
hemoglobin A1c
Time frame: change from baseline to 1 year after surgery
fasting glucose levels
Time frame: change from baseline to 1 month after surgery
fasting glucose levels
Time frame: change from baseline to 1 year after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Belfort De Aguiar, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, Type 1, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of use of hybrid closed-loop (HCL) system (time frame: up to 1 year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.