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

NCT ID: NCT04335513

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2023-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Early CGM-guided education and initiation of insulin therapy.

Intervention Type: 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.

Control

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.

Group Type: ACTIVE_COMPARATOR

Usual care: glucometer surveillance and basic education.

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brigitte I Frohnert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Barbara Davis Center for Diabetes, University of Colorado

Locations

Barbara Davis Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

19-1767

Identifier Type: -

Identifier Source: org_study_id