Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D

Status unconfirmed · Not applicable

Conditions studied: Type 1 Diabetes, Prediabetic State, Dysglycemia, Autoimmune Diabetes

In brief

This protocol is an intervention study to determine the best education and monitoring strategy for children ages 2-20 years with pre-symptomatic type 1 diabetes (T1D) because there currently exists no clinical guidelines for management of these children in early-stage T1D. This study hypothesizes that the trajectory of T1D can be changed, substantially reducing HbA1c and risk of DKA at diagnosis, through (1) careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, (2) staged education targeted to assist families in recognizing evolving dysglycemia, and (3) addressing glycemic abnormalities with early initiation of insulin.

Key facts

Study ID
NCT04335513
Run by
University of Colorado, Denver
People needed
84
Starts
2020-04-30
Expected to finish
2023-07-31
Last updated by the study team
2022-05-09

Who can join

Age: 2 and older, up to 20. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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