Type 1 DiabetesNCT04189510
Use of Closed Loop Insulin Delivery for Glucose Control in Patients With Insulin Dependent Diabetes Mellitus After Kidney Transplantation
A study testing Artificial Pancreas and Multiple Daily Injections in people with Type 1 Diabetes and Insulin-requiring Type 2 Diabetes Mellitus, run by University of Virginia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Insulin-requiring Type 2 Diabetes Mellitus, End Stage Renal Disease (ESRD)
- What is being tested?
- Artificial Pancreas and Multiple Daily Injections
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 31 Dec 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18.0 years old at time of consent
- History of insulin requiring diabetes mellitus, type 1 or type 2, who have end stage renal disease (ESRD)
- Expected to undergo deceased or living donor kidney transplant surgery
- History of insulin prescription (past or current use)
- If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study.
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- Total daily insulin dose (TDD) at least 10 U/day
- An understanding and willingness to follow the protocol and signed informed consent
Who cannot join
- Pregnancy or intent to become pregnant during the trial
- Currently breastfeeding or planning to breastfeed
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Having a family member(s) employed by Tandem Diabetes Care, Inc. or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
- Patients who have consented to participate in other interventional trials will be excluded or given the opportunity to exit from the study
About this study
Official title: Use of Closed Loop Insulin Delivery in the Immediate Postoperative Period Following Deceased Donor Kidney Transplant in Patients With Insulin Dependent Diabetes Mellitus
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).
Read the detailed description
The purpose of this study is to conduct a hypothesis-generating pilot study to assess the efficacy and safety of the closed loop control in kidney transplant recipients with history of insulin requiring diabetes mellitus in the early postoperative period.
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 12 weeks while treating themselves with multiple daily injections (MDI).
- Conditions
- Type 1 Diabetes, Insulin-requiring Type 2 Diabetes Mellitus, End Stage Renal Disease (ESRD)
- Being tested
- Artificial Pancreas, Multiple Daily Injections
- Keywords
- Type 1 Diabetes, Type 2 Diabetes, Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Kidney Transplant, Multiple Daily Injections (MDI)
- Medical subject headings
- Diabetes Mellitus, Type 1, Kidney Failure, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial PancreasDevice
The Artificial Pancreas will delivery insulin in place of Multiple Daily Injections after a kidney transplant.
Multiple Daily InjectionsOther
Multiple Daily Injections as standard of care post kidney transplant.
| Study group | Role | What they receive |
|---|---|---|
| Artificial Pancreas (AP) Insulin Group | Experimental | Not described Receives: Device: Artificial Pancreas |
| Multiple Daily Injections (MDI) Insulin Group | Active comparator | Not described Receives: Other: Multiple Daily Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Artificial Pancreas system
Safety will be assessed by using a continuous glucose monitor, which measures interstitial glucose concentrations every 5 minutes for 24 hours a day. We will measure percentage of time in 24 hour period that the continuous glucose monitor (CGM) measures interstitial glucose values <70 mg/dL per day as a surrogate assessment of safety.
Measured: 5 Weeks
Efficacy of Artificial Pancreas system
Efficacy will be assessed by using a continuous glucose monitor, which measures interstitial glucose concentrations every 5 minutes, 24 hours per day. We will measure percentage of time in 24 hour period that the continuous glucose monitor (CGM) measures interstitial glucose values between 70-180 mg/dL as a surrogate assessment of efficacy.
Measured: 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start1 Apr 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: ongoing concern of working with high-risk in-hospital transplant population during the various stages of the COVID-19 Pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc., Tandem Diabetes Care, Inc.
- Responsible party
- Principal investigator, Meaghan Stumpf, MD, University of Virginia
- Investigators
- Meaghan Stumpf, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189510
- Sponsor's protocol ID
- 190055
- Status last verified
- Nov 2021
- First submitted
- 22 Nov 2019
- Last updated
- 10 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Pending
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Closed Loop Insulin Delivery in the Immediate Postoperative Period Following Deceased Donor Kidney Transplant in Patients With Insulin Dependent Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04189510
- Acronym / sponsor ID
- 190055
- Conditions
- Type 1 Diabetes, Insulin-requiring Type 2 Diabetes Mellitus, End Stage Renal Disease (ESRD)
- Keywords
- Type 1 Diabetes, Type 2 Diabetes, Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Kidney Transplant, Multiple Daily Injections (MDI)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: ongoing concern of working with high-risk in-hospital transplant population during the various stages of the COVID-19 Pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- DexCom, Inc., Tandem Diabetes Care, Inc.
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Dec 2019 (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.
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).
Detailed description
The purpose of this study is to conduct a hypothesis-generating pilot study to assess the efficacy and safety of the closed loop control in kidney transplant recipients with history of insulin requiring diabetes mellitus in the early postoperative period.
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 12 weeks while treating themselves with multiple daily injections (MDI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial Pancreas (AP) Insulin Group | Experimental | Device: Artificial Pancreas |
| Multiple Daily Injections (MDI) Insulin Group | Active comparator | Other: Multiple Daily Injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18.0 years old at time of consent
- History of insulin requiring diabetes mellitus, type 1 or type 2, who have end stage renal disease (ESRD)
- Expected to undergo deceased or living donor kidney transplant surgery
- History of insulin prescription (past or current use)
- If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study.
Key exclusion criteria (5 listed)
- Pregnancy or intent to become pregnant during the trial
- Currently breastfeeding or planning to breastfeed
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Having a family member(s) employed by Tandem Diabetes Care, Inc. or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
- Patients who have consented to participate in other interventional trials will be excluded or given the opportunity to exit from the study
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 |
|---|---|---|
| Artificial PancreasThe Artificial Pancreas will delivery insulin in place of Multiple Daily Injections after a kidney transplant. | Device | Artificial Pancreas (AP) Insulin Group |
| Multiple Daily InjectionsMultiple Daily Injections as standard of care post kidney transplant. | Other | Multiple Daily Injections (MDI) Insulin Group |
Primary outcome
Safety of Artificial Pancreas system
Time frame: 5 Weeks
Safety will be assessed by using a continuous glucose monitor, which measures interstitial glucose concentrations every 5 minutes for 24 hours a day. We will measure percentage of time in 24 hour period that the continuous glucose monitor (CGM) measures interstitial glucose values <70 mg/dL per day as a surrogate assessment of safety.
Efficacy of Artificial Pancreas system
Time frame: 5 Weeks
Efficacy will be assessed by using a continuous glucose monitor, which measures interstitial glucose concentrations every 5 minutes, 24 hours per day. We will measure percentage of time in 24 hour period that the continuous glucose monitor (CGM) measures interstitial glucose values between 70-180 mg/dL as a surrogate assessment of efficacy.
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 10 Nov 2021.
- Individual participant dataSharing planned: Undecided. Pending
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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.
Meaghan Stumpf, MD principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Pancreas and Multiple Daily Injections in people with Type 1 Diabetes and Insulin-requiring Type 2 Diabetes Mellitus, run by University of Virginia.
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 8 inclusion and 5 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety of Artificial Pancreas system (time frame: 5 Weeks). The study lists 2 primary outcomes in all. 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 10 Nov 2021.