Islet TransplantationNCT03427931
CGM Use in Islet Transplant Recipients
A study testing Continuous Glucose Monitor (CGM) in people with Islet Transplantation and Type1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial summary
A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Islet Transplantation, Type1 Diabetes Mellitus
- What is being tested?
- Continuous Glucose Monitor (CGM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 11 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Type 1 Diabetes Mellitus
- Recipient of Islet Transplantation
- Age 18 or older
- Females, not currently know to be pregnant
- Demonstration of proper mental status and cognition for the study
- Understanding and willingness to follow the protocol and informed consent form
- Access to the internet and willingness to upload data during the study, including use of personal laptop
Who cannot join
- Pregnancy and intent to become pregnant during trial
- Use of acetaminophen (such as Tylenol)
- Current enrollment in another intervention clinical trial that affects glucose variability
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
About this study
Official title: Continuous Glucose Monitoring in Islet Transplant Recipients
A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.
Read the detailed description
Subjects who have an Islet Transplantation may have several outcomes including time when insulin is not required followed in some cases by additional insulin for glucose control as patients get further away from transplantation. It is unclear what role automated insulin delivery systems will have in addressing glucose variability in this group of patients who may have some amount of islet function. As a precursor to understanding ways in which automated insulin delivery systems may need to be adapted, we propose to gather data on glucose variability and insulin regimens in individuals who have undergone an islet transplantation.
- Conditions
- Islet Transplantation, Type1 Diabetes Mellitus
- Being tested
- Continuous Glucose Monitor (CGM)
- Keywords
- Type 1 Diabetes Mellitus, Islet Transplantation, Continuous Glucose Monitor (CGM)
- 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.
Continuous Glucose Monitor (CGM)Other
Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitor (CGM) | Experimental | Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months. Receives: Other: Continuous Glucose Monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Time in Range 70-180 mg/dL by CGM
Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL
Measured: 28-90 days
Secondary outcomes (1)
Percentage Time in Range <70 mg/dL by CGM
Descriptive glycemic analyses based on CGM data with glucose range <70 mg/dL
Measured: 28-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Feb 2018
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Islet TransplantationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Sue Brown, University of Virginia
- Investigators
- Sue A Brown, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427931
- Sponsor's protocol ID
- 20294
- Status last verified
- Jul 2020
- First submitted
- 29 Dec 2017
- Last updated
- 7 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Islet Transplant Recipients
- ClinicalTrials.gov ID
- NCT03427931
- Acronym / sponsor ID
- 20294
- Conditions
- Islet Transplantation, Type1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Islet Transplantation, Continuous Glucose Monitor (CGM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 7 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.
Detailed description
Subjects who have an Islet Transplantation may have several outcomes including time when insulin is not required followed in some cases by additional insulin for glucose control as patients get further away from transplantation. It is unclear what role automated insulin delivery systems will have in addressing glucose variability in this group of patients who may have some amount of islet function. As a precursor to understanding ways in which automated insulin delivery systems may need to be adapted, we propose to gather data on glucose variability and insulin regimens in individuals who have undergone an islet transplantation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitor (CGM) | Experimental | Other: Continuous Glucose Monitor (CGM)Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 1 Diabetes Mellitus
- Recipient of Islet Transplantation
- Age 18 or older
- Females, not currently know to be pregnant
- Demonstration of proper mental status and cognition for the study
Key exclusion criteria (3 listed)
- Pregnancy and intent to become pregnant during trial
- Use of acetaminophen (such as Tylenol)
- Current enrollment in another intervention clinical trial that affects glucose variability
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 (CGM)Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months. | Other | Continuous Glucose Monitor (CGM) |
Primary outcome
Percentage Time in Range 70-180 mg/dL by CGM
Time frame: 28-90 days
Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL
1 secondary outcome
Percentage Time in Range <70 mg/dL by CGM
Time frame: 28-90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Islet Transplantation
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Autologous Mesenchymal Stromal Cells and Islet Co-transplantation in TP-IAT
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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.
Sue A Brown, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor (CGM) in people with Islet Transplantation and Type1 Diabetes Mellitus, run by University of Virginia 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 7 inclusion and 3 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 7 Aug 2020. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Time in Range 70-180 mg/dL by CGM (time frame: 28-90 days). 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 7 Aug 2020.