CGM Use in Islet Transplant Recipients

Study Overview
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Brief Summary
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A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.

Detailed Description
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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.

Official Title
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Continuous Glucose Monitoring in Islet Transplant Recipients

Conditions
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Islet Transplantation, Type1 Diabetes Mellitus

Intervention / Treatment
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* Other: Continuous Glucose Monitor (CGM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitor (CGM)<br>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. | Other: Continuous Glucose Monitor (CGM)<br>* Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes Mellitus, Islet Transplantation, Continuous Glucose Monitor (CGM)