Status:
UNKNOWN
Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Conditions:
Type 1 Diabetes
Prediabetic State
Eligibility:
All Genders
2-20 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- Individuals identified in stage 2 T1D through ongoing screening studies at the Barbara Davis Center (ASK, DAISY, TrialNet, and TEDDY) who have given permission to be contacted about study opportunities.
- Presence of islet autoimmunity with high risk of progression:
- i. positive for multiple islet autoantibodies at 2 or more visits -OR- ii. positive for a single high-affinity islet autoantibody at 2 or more visits
- Evidence of dysglycemia (Stage 2 T1D) using any one of the following criteria:
- I. Americal Diabetes Association (ADA) criteria:
- fasting plasma glucose 100-125 mg/dL
- OR 2-hour OGTT plasma glucose of 140-199 mg/dL
- OR A1c 5.7-6.4%
- OR ≥10% increase in A1c from previous visit
- II. Dysglycemia on OGTT (TrialNet Criteria):
- a. glucose above 200 mg/dL on 30, 60 OR 90 minute values
- III. Dysglycemia on CGM worn for at least 5 days:
- ≥15% of values above 140 mg/dL
- OR peaks ≥ 200 mg/dL on ≥2 days
- OR average sensor glucose ≥120 mg/dL
- IV. Dysglycemia on finger stick blood glucose:
- Fasting BG above 110 mg/dL on 2 or more days
- OR 2 hour post-meal BG above 150 mg/dL on ≥ 2 days
- OR single random BG \> 200 mg/dL
Exclusion
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04335513
Start Date
April 30 2020
End Date
July 31 2023
Last Update
May 9 2022
Active Locations (1)
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1
Barbara Davis Center
Aurora, Colorado, United States, 80045