Continuous Glucose Monitor Derived Glucose Dynamic Index as a Diagnostic Marker for Progression to Type 1 Diabetes

VS

Viral Shah

Principal Investigator

Status: Enrolling By Invitation Ages: 4 Years - 100 Years Gender: All Genders Phase: N/A 2 Locations

Brief Description

This study is being done to develop a way to use information from a continuous glucose monitor (CGM) to predict a person’s progression through the Stages of Type 1 Diabetes (T1D).

A CGM is a wearable device that continuously measures and displays a person’s blood sugar levels throughout the day and night by sensing the glucose (blood sugar levels) in the fluid under the skin, providing real-time updates without the need for finger pricks. 

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed Description

This study will include 2 groups identified as being in Stage 1 or Stage 2 of T1D based on either data from their TrialNet Pathway to Prevention visits or from data that
has previously been obtained through clinical monitoring.  Participants will be asked to wear a CGM every 3 months and have an OGTT every 6 months for 2 years or until diagnosed with Stage 3 T1D. 

Eligibility of study

Inclusion Criteria
• ≥4 years of age and older
• Participants in Stage 1 or Stage 2 T1D monitored in the Pathway to Prevention (PTP) study at
a Type 1 Diabetes TrialNet center. Participants that exit PTP due to use of teplizumab or
enrollment into a prevention trial, may continue in study if all other criteria are met.
• For IU ONLY: Participants in Stage 1 or Stage 2 T1D monitored outside of TrialNet Pathway to
Prevention study (PTP).
• Willing to use a continuous glucose monitoring (CGM) system with a compatible smartphone
for glucose data collection.

Exclusion Criteria
• History of diabetes
• Pregnancy
• Allergy to adhesives.
• Use of any medication that in the judgement of the investigator will affect the wearing of the
sensors or glucose metabolism.
• Individuals with severe concurrent medical conditions that could confound glucose monitoring
data (e.g., terminal illness, or major organ failure).
• In the opinion of investigator, any condition that may confound study results or may hinder
participants’ ability to comply with study protocol.
 

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.