Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D (TESS)
Type 1 Diabetes, Prediabetic State, Dysglycemia
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Islet autoimmunity
Eligibility Criteria
- 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
Sites / Locations
- Barbara Davis Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention
Control
Early diabetes management and education including focused education based on pathophysiology of type 1 diabetes, factors which impact blood glucose, and effects of insulin using data from continuous glucose monitoring device (CGM) worn unblinded at least 20 days per month with interpretation and education on results. Early initiation of insulin therapy, when warranted based on a pattern of prolonged or repeated high blood glucose values.
Usual education and advice on glycemic surveillance based on protocols of TEDDY/DAISY/ASK (ongoing studies at BDC). This includes: blood glucose checks 2-3 times per month, participant-led contact with study personnel when abnormalities are noted and transition to clinical care when criteria for clinical type 1 diabetes are met.