Islet Transplantation, Type1 Diabetes Mellitus
Conditions
Keywords
Type 1 Diabetes Mellitus, Islet Transplantation, Continuous Glucose Monitor (CGM)
Brief summary
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.
Interventions
OTHERContinuous 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.
Sponsors
DexCom, Inc.
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Time in Range 70-180 mg/dL by CGM | 28-90 days | Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Time in Range <70 mg/dL by CGM | 28-90 days | Descriptive glycemic analyses based on CGM data with glucose range \<70 mg/dL |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitor (CGM) |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 10 |
| Hemoglobin A1c | 6.9 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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
Time frame: 28-90 days
Population: Participants with available CGM data for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitor (CGM) | Percentage Time in Range 70-180 mg/dL by CGM | 77 percentage of CGM readings 70-180mg/dL | Standard Deviation 12 |
Secondary
Percentage Time in Range <70 mg/dL by CGM
Descriptive glycemic analyses based on CGM data with glucose range \<70 mg/dL
Time frame: 28-90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitor (CGM) | Percentage Time in Range <70 mg/dL by CGM | 3.6 percentage of CGM readings <70mg/dL | Standard Deviation 3.2 |