N/A
N=7
CGM Use in Islet Transplant Recipients
Islet Transplantation · Type1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03427931 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Percentage Time in Range 70-180 mg/dL by CGM — 77 percentage of CGM readings 70-180mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Glucose Monitor (CGM) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Time in Range 70-180 mg/dL by CGM |
77 | — |
| SECONDARY Percentage Time in Range <70 mg/dL by CGM |
3.6 | — |
Summary
A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03427931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.