Diabetes MellitusEarly Phase 1NCT04742023
Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation
A Early Phase 1 study testing Continuous Glucose Monitor Application, Finger Stick Glucose Measurement and Insulin in people with Diabetes Mellitus, run by Northwell Health at 1 site in United States.
Trial summary
This will be a prospective, randomized, single-blinded controlled trial in which the investigators evaluate post-operative serum glucose control using conventional point-of-care glucose monitoring in the morning and before meals (standard of care) versus continuous glucose monitoring using the Medtronic Guardian™… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Continuous Glucose Monitor Application, Finger Stick Glucose Measurement and Insulin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2020to 21 Dec 2023
- Phase
- Early Phase 1
- 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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older
- Undergoing first-time renal transplantation
- Have a pre-existing diagnosis of Type 2 diabetes mellitus
Who cannot join
- Age less than 18 years
- Use of insulin pump at time of transplant
- Insulin infusion requirement during hospitalization
- Pregnancy or lactation
- Known allergic reaction to Guardian™ Sensor 3 or adhesives
- History of hypoglycemia unawareness
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
This will be a prospective, randomized, single-blinded controlled trial in which the investigators evaluate post-operative serum glucose control using conventional point-of-care glucose monitoring in the morning and before meals (standard of care) versus continuous glucose monitoring using the Medtronic Guardian™ Sensor 3 continuous glucose monitor. The investigators will compare the average daily glucose level in the post-operative period (through post-operative day five) between the two arms in patients with diabetic nephropathy immediately post-renal transplant. This will serve as a pilot study to in order to power a main study.
- Conditions
- Diabetes Mellitus
- Being tested
- Continuous Glucose Monitor Application, Finger Stick Glucose Measurement, Insulin, Continuous Glucose Monitor Placebo Applied
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitor ApplicationDevice
The Guardian™ Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied and values interpreted by nursing.
Finger Stick Glucose MeasurementDiagnostic test
Patients post-renal transplant will have finger-stick glucose measurements checked prior to meals.
InsulinDrug
Insulin will be administered.
Continuous Glucose Monitor Placebo AppliedDevice
The Guardian™ Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied however values will not be interpreted.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Not described Receives: Device: Continuous Glucose Monitor Application; Diagnostic Test: Finger Stick Glucose Measurement; Drug: Insulin |
| Control Arm | Placebo comparator | Not described Receives: Diagnostic Test: Finger Stick Glucose Measurement; Drug: Insulin; Device: Continuous Glucose Monitor Placebo Applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Glucose
The primary outcome of this study is average daily glucose level.
Measured: Postoperative day 1 - 5
Secondary outcomes (3)
Number of Hyperglycemic Episodes
The number of episodes where glucose goes from <180mg/dl to ≥ 180 mg/dl.
Measured: Postoperative days 1-5
Number of Hypoglycemic Episodes
The number of episodes where glucose levels go from > 80 mg/dl to ≤ 80 mg/dl
Measured: Postoperative days 1-5
Total Insulin Use
The total number of insulin units used
Measured: Postoperative days 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start21 Apr 2020
- Primary completion21 Nov 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742023
- Sponsor's protocol ID
- 20-0066
- Status last verified
- Dec 2023
- First submitted
- 28 Jan 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation
- ClinicalTrials.gov ID
- NCT04742023
- Acronym / sponsor ID
- 20-0066
- Conditions
- Diabetes Mellitus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 5 Feb 2021 (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 will be a prospective, randomized, single-blinded controlled trial in which the investigators evaluate post-operative serum glucose control using conventional point-of-care glucose monitoring in the morning and before meals (standard of care) versus continuous glucose monitoring using the Medtronic Guardian™ Sensor 3 continuous glucose monitor. The investigators will compare the average daily glucose level in the post-operative period (through post-operative day five) between the two arms in patients with diabetic nephropathy immediately post-renal transplant. This will serve as a pilot study to in order to power a main study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Continuous Glucose Monitor Application, Diagnostic Test: Finger Stick Glucose Measurement, Drug: Insulin |
| Control Arm | Placebo comparator | Diagnostic Test: Finger Stick Glucose Measurement, Drug: Insulin, Device: Continuous Glucose Monitor Placebo Applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or older
- Undergoing first-time renal transplantation
- Have a pre-existing diagnosis of Type 2 diabetes mellitus
Key exclusion criteria (6 listed)
- Age less than 18 years
- Use of insulin pump at time of transplant
- Insulin infusion requirement during hospitalization
- Pregnancy or lactation
- Known allergic reaction to Guardian™ Sensor 3 or adhesives
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 |
|---|---|---|
| Continuous Glucose Monitor ApplicationThe Guardian™ Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied and values interpreted by nursing. | Device | Intervention Arm |
| Finger Stick Glucose MeasurementPatients post-renal transplant will have finger-stick glucose measurements checked prior to meals. | Diagnostic test | Control Arm, Intervention Arm |
| InsulinInsulin will be administered. | Drug | Control Arm, Intervention Arm |
| Continuous Glucose Monitor Placebo AppliedThe Guardian™ Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied however values will not be interpreted. | Device | Control Arm |
Primary outcome
Average Daily Glucose
Time frame: Postoperative day 1 - 5
The primary outcome of this study is average daily glucose level.
3 secondary outcomes
Number of Hyperglycemic Episodes
Time frame: Postoperative days 1-5
Number of Hypoglycemic Episodes
Time frame: Postoperative days 1-5
Total Insulin Use
Time frame: Postoperative days 1-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Continuous Glucose Monitor Application, Finger Stick Glucose Measurement and Insulin in people with Diabetes Mellitus, run by Northwell Health 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 26 Dec 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average Daily Glucose (time frame: Postoperative day 1 - 5). 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 26 Dec 2023.