CGM Use in Islet Transplant Recipients

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University of Virginia

Status

Completed

Conditions

Islet Transplantation
Type1 Diabetes Mellitus

Treatments

Other: Continuous Glucose Monitor (CGM)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03427931
20294

Details and patient eligibility

About

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

Full 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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Continuous Glucose Monitor (CGM)
Experimental group
Description:
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.
Treatment:
Other: Continuous Glucose Monitor (CGM)

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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