NCT04335513

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Specific Aims: Perform randomized controlled trial of intensive follow-up of stage 2 T1D participants utilizing continuous glucose monitoring (CGM) technology and early education of families to guide early insulin therapy with the goals of: maintaining HbA1c less than 7.0%. avoiding adverse outcomes: ER visits, hospitalizations, DKA and severe hypoglycemia improving diabetes knowledge through optimal planned education as opposed to 'a crash course' at unexpected diagnosis event. evaluating patient/caregiver satisfaction with diabetes care received evaluating impact of activity on glycemic profile Collect longitudinal biomarkers of beta-cell stress and dysfunction in stage 2 T1D. Use longitudinal CGM data combined with "gold-standard" OGTT and HbA1c measures to provide evidence for CGM-based diagnostic criteria for stage 2 and stage 3 T1D. Perform cost-analysis of intensive follow up protocol.

Conditions

• Type 1 Diabetes
• Prediabetic State
• Dysglycemia
• Autoimmune Diabetes

Interventions

Type	Name	Description
OTHER	Early CGM-guided education and initiation of insulin therapy.	Careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, staged education targeted to assist families in recognizing evolving dysglycemia, and addressing glycemic abnormalities with early initiation of insulin can substantially reduce the HbA1c and risk of DKA at diagnosis, thereby changing the trajectory of the disease course.
OTHER	Usual care: glucometer surveillance and basic education.	* Usual education and advice on glycemic surveillance based on protocols of TEDDY/DAISY/ASK. * Blinded CGM for 10 days every 3 months to collect data on glycemic profile with basic feedback regarding changes.

Timeline

• Start date: 2020-04-30
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2020-04-06
• Last updated: 2022-05-09

Locations

1 site across 1 country: United States