Type1 Diabetes Mellitus Clinical Trial
Official title:
Continuous Glucose Monitoring in Islet Transplant Recipients
NCT number | NCT03427931 |
Other study ID # | 20294 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2018 |
Est. completion date | July 11, 2019 |
Verified date | July 2020 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.
Status | Completed |
Enrollment | 7 |
Est. completion date | July 11, 2019 |
Est. primary completion date | July 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Center for Diabetes Technology | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | DexCom, Inc., University of Virginia Strategic Investment Fund |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 28-90 days | |
Secondary | Percentage Time in Range <70 mg/dL by CGM | Descriptive glycemic analyses based on CGM data with glucose range <70 mg/dL | 28-90 days |
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