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

Not Applicable

• Conditions: Type 1 Diabetes; Prediabetic State; Dysglycemia; Autoimmune Diabetes
• Interventions: Other: Early CGM-guided education and initiation of insulin therapy.

• Registration Number: NCT04335513
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-04-03
• Study First Posted: 2020-04-06
• Study Start: 2020-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Early CGM-guided education and initiation of insulin therapy.	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.

Primary Outcome Measures

Name	Time	Method
Continuous glucose monitor (CGM) % time >140 mg/dL	Baseline and 3, 6, 9 and 12 months	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.
Change in Diabetes Knowledge from baseline to 6 month follow-up.	Baseline, 6 months	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

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline and 3, 6, 9 and 12 months	HbA1c from baseline to 52 weeks, adjusted for baseline
Change in C-peptide response to Oral Glucose Tolerance Test (OGTT)	Baseline, 6 months, 12 months	C-peptide measurement during standard OGTT, Area under the curve (AUC)
Change in insulin response to Oral Glucose Tolerance Test (OGTT)	Baseline, 6 months, 12 months	insulin measurement during standard OGTT, Area under the curve (AUC)
Change in Pediatric Quality of Life Inventory (PedsQL 4.0) score over time	Baseline and 3, 6, 9 and 12 months	The PedsQL 4.0 measures health-related quality of life across the domains of Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning.; ThePedsQL has parallel forms for parents of children aged 2-4, 5-7, 8-12, and 13-18 years. The child version has parallel forms for children aged 5-7, 8-12, and 13-18. Responses to items use a 5-point Likert scale (0 = never a problem, 4 = almost always a problem). Items are reverse scored and transformed to a 0 to 100 scale with higher scores indicating better quality of life.
% with HbA1c <7.0%	Baseline and 3, 6, 9 and 12 months	Percentage of individuals in each group with HbA1c \<7.0%
Continuous glucose monitor (CGM) mean sensor glucose level (mg/dL)	Baseline and 3, 6, 9 and 12 months	Data obtained for Dexcom G6 wear with at least 5 days of data.
Continuous glucose monitor (CGM) standard deviation sensor glucose level (mg/dL)	Baseline and 3, 6, 9 and 12 months	Data obtained for Dexcom G6 wear with at least 5 days of data.
Continuous glucose monitor (CGM) coefficient of variation sensor glucose level (mg/dL)	Baseline and 3, 6, 9 and 12 months	Data obtained for Dexcom G6 wear with at least 5 days of data.
Continuous glucose monitor (CGM) % time in range 60-140 mg/dL	Baseline and 3, 6, 9 and 12 months	Data obtained for Dexcom G6 wear with at least 5 days of data.
Diabetes attitude survey change over time	Baseline, 6 months, 12 months	10 item survey, each item answered on a likert scale from 1-5: (1) strongly disagree to (5) strongly agree. Scoring is on 4 scales: (1) "Value of Tight Control", scored on 4-20 points with higher score indicating agreement with importance of control; (2) "Psychosocial Impact", scored on 2-10 points with higher score indicating agreement with high impact of diabetes on psychosocial factors; (3) "Patient Autonomy", scored on 2-10 points with higher score indicating agreement with value of autonomy; and (4) "Confidence", scored on 2-10 points with higher score indicating confidence in knowledge and skills.

Trial Locations

Locations (1)

Barbara Davis Center; 🇺🇸 Aurora, Colorado, United States