Strategies to Enhance New CGM Use in Early Childhood (SENCE)

Study Overview
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Brief Summary
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The primary objective of this study is to compare the efficacy and safety of CGM alone and CGM combined with a family behavioral intervention with a control group using home blood glucose monitoring (BGM) alone.

Detailed Description
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Although prior studies have not demonstrated that continuous glucose monitoring (CGM) use results in improved glycemic control in children <8 years of age, many of the barriers to CGM efficacy in this age group may have been due to problems in the wearability and accuracy of prior generation devices, as well as to the setting of glycemic targets aimed primarily at preventing hypoglycemia at all costs. There may also be behavioral barriers to consistent and effective CGM use in this age range. The goal of this study is to assess the impact of CGM alone and CGM combined with a family behavioral intervention focused on supporting CGM use on glycemic control in very young children with T1D compared with usual care without CGM.

Official Title
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Strategies to Enhance New CGM Use in Early Childhood: A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Youth < 8 With Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: CGM + Family Behavioral Intervention
* Device: Standard CGM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator Age 2-<8 years at consent Diabetes duration ≥ 6 months Total daily insulin ≥ 0.3 units per kg per day HbA1c 7.0% to <10.0% (Point of care device or local lab measured within 30 days of screening visit used to assess eligibility) No use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days Insulin regimen involves either use of a consistent insulin regimen with an insulin pump in the last 3 months or at least 3 multiple daily injections of basal and bolus (meal time) analogue insulin in the last 3 months (e.g. no change from injections to pump or vice versa in the last 3 months), with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections). Perform at least 3 blood glucose meter checks per day from self-report at screening and meter download during blinded CGM run in Not currently using and no plans to begin non-insulin medication for blood glucose lowering during the course of the study Parent or guardian comprehend written and spoken English (This requirement is due to the fact that the questionnaires to be used as outcome measures do not have validated versions in other languages, and interventions will be delivered in English only for the RCT to ensure standardization/fidelity checks across sites). Parent understands the study protocol and agrees to it No expectation that participant/parent will be moving out of the area of the clinical center during the next 12 months, unless the move will be to an area served by another study center. Exclusion Criteria: Use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days Unable to use CGM device for minimum number of hours during blinded run-in period or skin reaction from adhesive that would preclude participation in the randomized trial The presence of a significant medical disorder or use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol. More than 1 episode of SH or DKA in the past 6 months (not including DKA at time of dx). The presence of any of the following diseases: Asthma if treated with systemic or daily inhaled corticosteroids in the last 6 months (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment) Cystic fibrosis (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment) Inpatient psychiatric treatment in the past 6 months for either child participant or the primary care giver Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial Participation of parent or child in a diabetes related intervention study in past 6 weeks. Any medical, psychological or social situation where per investigator discretion it may be difficult for family or child to participate fully in the intervention Another member of the same household is participating in this study.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CGM + Family Behavioral Intervention<br>CGM training for CGM groups using a standard curriculum will take place at the 1, 3 and 6 week visits in addition to the training at baseline. The family behavioral intervention will be delivered by a study coordinator (separate coordinator from the CGM instruction) at the 1, 3, 6, 13 and 19 week visits and is expected to take approximately 30 minutes. | Behavioral: CGM + Family Behavioral Intervention<br>* use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence<br>* Other names: FBI;|
| Active Comparator: Standard CGM<br>Each participant will be asked to use a CGM sensor on a daily basis, inserting a new sensor as needed with a maximum of 7 days of wear per sensor. A home BGM will be used for calibration of the CGM sensor. Additional BGM glucose measurements may be performed by the participant at any time, particularly prior to making a real-time management decision based on the CGM glucose reading. Participants will be instructed to use the CGM as per the FDA labeling. | Device: Standard CGM<br>* use of CGM alone to assess CGM adherence<br>|
| No Intervention: BGM - usual care control group<br>A BGM will be used for a finger stick blood glucose check with a recommendation of at least 4 times a day. BGM data will be downloaded and reviewed with the participant at each visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in glucose range 70-180 | The primary outcome will be three 2 group comparisons of the change from baseline in the percentage of sensor values in the target range (70-180 mg/dL), in an ANCOVA model adjusted for the baseline value and factors used to stratify randomization with clinical site as a random effect. Seven days of sensor glucose values during the week prior to the 6, 13, 19 and 26 week clinic visits will be used in analysis for the CGM groups to match up with the blinded CGM placed at each visit in the control group. The CGM data will be pooled across each visit where CGM data are collected during follow up for the primary analysis. | Up to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c at 6-months | A secondary outcome is to compare HbA1c at 6-months, adjusted for baseline. | 6 Months | 
| % HbA1c <7.0% |  | 6 Months | 
| % HbA1c <7.5% |  | 6 Months | 
| % with relative reduction in HbA1c >=10% |  | 6 Months | 
| % with absolute reduction in HbA1c >=0.5% |  | 6 Months | 
| % with absolute reduction in HbA1c >=1% |  | 6 Months | 
| % with absolute reduction in HbA1c >=1% or HbA1c <7.0% |  | 6 Months | 
| Mean glucose |  | 6 Months | 
| Glucose variability measured by coefficient of variation |  | 6 Months | 
| % time >180 mg/dl |  | 6 Months | 
| % time >250 mg/dl |  | 6 Months | 
| % time >300 mg/dl |  | 6 Months | 
| Area under the curve 180 mg/dl |  | 6 Months | 
| High blood glucose index (HBGI) |  | 6 Months | 
| % time <54 mg/dl |  | 6 Months | 
| % time <60 mg/dl |  | 6 Months | 
| % time <70 mg/dl |  | 6 Months | 
| Area over the curve 70 mg/dl |  | 6 Months | 
| Low blood glucose index (LBGI) |  | 6 Months | 
| Hypoglycemic events (using <54 mg/dl) |  | 6 Months | 
| WHO-5 Well Being Index | Survey containing 5 questions with possible responses 0-5. The raw score is calculated by summing the responses. The raw score ranges from 0-25. A percentage score ranging from 0 to 100 is obtained by multiplying the raw score by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life. | 6 Months | 
| Hypoglycemia Fear Survey Total Score | Survey containing 26 questions with possible responses 0-4. Total score is calculated by taking the mean of the non-missing responses and multiplying by 25 to put on the scale 0-100. A higher score indicates more fear. | 6 Months | 
| Hypoglycemia Fear Survey Worry Subscale | Survey containing 26 questions with possible responses 0-4. Worry subscale score is calculated by taking the mean of the non-missing responses to questions 11-26 and multiplying by 25 to put on the scale 0-100. A higher score indicates more fear. | 6 Months | 
| Diabetes Technology Questionnaire | Survey containing 30 questions with possible responses 0-4. Total score is calculated by taking the mean of the non-missing responses and multiplying by 100 to put on the scale 0-100. A higher total score indicates less of a problem. | 6 Months | 
| Problem Areas in Diabetes - Parent (PAID-PR) | Survey containing 18 questions with possible responses 0-4. Total score is calculated by reverse scoring each item, then taking the mean of the non-missing responses. The score is then multiplied by 25 to put on the scale 0-100. A higher total score indicates more burden. | 6 Months | 
| Diabetes Family Impact Survey | Survey containing 15 questions with possible responses 0-3. Total score is calculated by taking the mean of the non-missing responses. Then multiply by 100 and divide by 3 to put on the scale 0-100. A higher total score indicates more negative impact. | 6 Months | 
| Satisfaction Questionnaire | Section 2 of the satisfaction questionnaire contains 8 questions for the CGM groups only with possible responses 0-4. Total score is calculated by taking the mean of the non-missing responses and multiplying by 25 to put on the scale 0-100. A higher total score indicates more satisfaction with the study. | 6 Months |