Continuous Glucose Monitor Derived Glucose Dynamic Index as a Diagnostic Marker for Progression to Type 1 Diabetes (Dx-T1D)
Investigating Continuous Glucose Monitor for Type 1 Diabetes
Viral Shah
Primary Investigator
Brief description of study
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.
Detailed description of study
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
You may be eligible for this study if you meet the following criteria:
- Conditions: Type 1 Diabetes, T1D
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Age: 4 years - 100 years
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Gender: All
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.
This study investigates how information from a continuous glucose monitor (CGM) can predict the progression of Type 1 diabetes (T1D). Type 1 diabetes is a chronic disease where the body's defense system mistakenly attacks specific cells within the pancreas, which make insulin. Insulin helps control sugar in the blood. When these cells are damaged, they cannot make enough insulin. This means people with Type 1 diabetes need to take insulin every day to keep their blood sugar at safe levels. A CGM is a wearable device that measures blood sugar levels continuously by sensing glucose in the fluid under the skin, providing real-time updates without finger pricks.
Participants will be asked to wear a CGM every three months and undergo an oral glucose tolerance test (OGTT) every six months. The study will include individuals identified as being in Stage 1 or Stage 2 of T1D. The procedures will continue for up to two years or until a participant progresses to Stage 3 T1D.
- Who can participate: Individuals aged 4 years and older in Stage 1 or Stage 2 of Type 1 diabetes and monitored in the Pathway to Prevention study at a TrialNet center are eligible. Exclusions include a history of diabetes, pregnancy, or severe medical conditions.
- Study details: Participants must use a compatible smartphone for glucose data collection. The study involves regular CGM use and glucose testing.
- Study timelines: The study will last 2 years.
