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

University of Colorado, Denver84 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

1. 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. 2. 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 3. Evidence of dysglycemia (Stage 2 T1D) using any one of the following criteria: I. Americal Diabetes Association (ADA) criteria: 1. fasting plasma glucose 100-125 mg/dL 2. OR 2-hour OGTT plasma glucose of 140-199 mg/dL 3. OR A1c 5.7-6.4% 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: 1. ≥15% of values above 140 mg/dL 2. OR peaks ≥ 200 mg/dL on ≥2 days 3. OR average sensor glucose ≥120 mg/dL IV. Dysglycemia on finger stick blood glucose: 1. Fasting BG above 110 mg/dL on 2 or more days 2. OR 2 hour post-meal BG above 150 mg/dL on ≥ 2 days 3. OR single random BG \> 200 mg/dL

Outcomes

Primary Outcomes

Change in Diabetes Knowledge from baseline to 6 month follow-up.

35-item diabetes questionnaire with possible responses true/false/don't know. Total score is the number of correct answers out of 35, with more correct answers indicating higher knowledge. Change from baseline to 6-month follow-up will be compared between groups

Time frame: Baseline, 6 months

Continuous glucose monitor (CGM) % time >140 mg/dL

Data obtained for Dexcom G6 wear with at least 5 days of data at each time point. Continuous glucose monitor (CGM) % time \>140 mg/dL will be analyzed using linear mixed models incorporating data from all 5 time points, with an interaction between group and time to test for differences in change in outcome over time. Contrast statements will be used to test for comparisons of intervention vs controls.