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

NCT04335513 | Unknown

• 1 other identifier: 19-1767
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Type 1 Diabetes; Prediabetic State; Dysglycemia; Autoimmune Diabetes

Keywords

Islet autoimmunity

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline and 3, 6, 9 and 12 months

Secondary Outcomes (10)

• Change in HbA1c

  Baseline and 3, 6, 9 and 12 months

• % with HbA1c <7.0%

  Baseline and 3, 6, 9 and 12 months

• Continuous glucose monitor (CGM) % time in range 60-140 mg/dL

  Baseline and 3, 6, 9 and 12 months

• Continuous glucose monitor (CGM) mean sensor glucose level (mg/dL)

  Baseline and 3, 6, 9 and 12 months

• Continuous glucose monitor (CGM) standard deviation sensor glucose level (mg/dL)

  Baseline and 3, 6, 9 and 12 months

Other Outcomes (23)

• Activity Monitoring daily steps

  Monthly for months 0, 1, 2, 3, 4, 5, and 6 of study

• Parental anxiety regarding diabetes risk

  Baseline, 6 and 12 months

• Parental depression symptoms.

  Baseline, 6 and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Early CGM-guided education and initiation of insulin therapy.

Control

ACTIVE COMPARATOR

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.

Other: Usual care: glucometer surveillance and basic education.

Interventions

Early CGM-guided education and initiation of insulin therapy. OTHER

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.

Intervention

Usual care: glucometer surveillance and basic education. OTHER

* 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.

Control

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Brigitte I Frohnert, MD, PhD

  Barbara Davis Center for Diabetes, University of Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: April 6, 2020
• Study Start: April 30, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)