Clinical trial NCT02912728: Strategies to Enhance New CGM Use in Early Childhood (SENCE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
name: Indiana University School of Medicine
First posted: 2016-09-23
Enrollment: 143
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator
2. Age 2-\<8 years at consent
3. Diabetes duration ≥ 6 months
4. Total daily insulin ≥ 0.3 units per kg per day
5. HbA1c 7.0% to \<10.0% (Point of care device or local lab measured within 30 days of screening visit used to assess eligibility)
6. No use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days
7. 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).
8. Perform at least 3 blood glucose meter checks per day from self-report at screening and meter download during blinded CGM run in
9. Not currently using and no plans to begin non-insulin medication for blood glucose lowering during the course of the study
10. 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).
11. Parent understands the study protocol and agrees to it
12. 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:

1. Use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days
2. 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
3. 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.
4. More than 1 episode of SH or DKA in the past 6 months (not including DKA at time of dx).
5. 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)
6. Inpatient psychiatric treatment in the past 6 months for either child participant or the primary care giver
7. Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial
8. Participation of parent or child in a diabetes related intervention study in past 6 weeks.
9. Any medical, psychological or social situation where per investigator discretion it may be difficult for family or child to participate fully in the intervention
10. Another member of the same household is participating in this study.

Primary outcomes:
measure: Time in glucose range 70-180
timeFrame: Up to 26 weeks
Secondary outcomes:
measure: HbA1c at 6-months
timeFrame: 6 Months
measure: % HbA1c <7.0%
timeFrame: 6 Months
measure: % HbA1c <7.5%
timeFrame: 6 Months
measure: % with relative reduction in HbA1c >=10%
timeFrame: 6 Months
measure: % with absolute reduction in HbA1c >=0.5%
timeFrame: 6 Months
measure: % with absolute reduction in HbA1c >=1%
timeFrame: 6 Months
measure: % with absolute reduction in HbA1c >=1% or HbA1c <7.0%
timeFrame: 6 Months
measure: Mean glucose
timeFrame: 6 Months
measure: Glucose variability measured by coefficient of variation
timeFrame: 6 Months
measure: % time >180 mg/dl
timeFrame: 6 Months
measure: % time >250 mg/dl
timeFrame: 6 Months
measure: % time >300 mg/dl
timeFrame: 6 Months
measure: Area under the curve 180 mg/dl
timeFrame: 6 Months
measure: High blood glucose index (HBGI)
timeFrame: 6 Months
measure: % time <54 mg/dl
timeFrame: 6 Months
measure: % time <60 mg/dl
timeFrame: 6 Months
measure: % time <70 mg/dl
timeFrame: 6 Months
measure: Area over the curve 70 mg/dl
timeFrame: 6 Months
measure: Low blood glucose index (LBGI)
timeFrame: 6 Months
measure: Hypoglycemic events (using <54 mg/dl)
timeFrame: 6 Months
measure: WHO-5 Well Being Index
timeFrame: 6 Months
measure: Hypoglycemia Fear Survey Total Score
timeFrame: 6 Months
measure: Hypoglycemia Fear Survey Worry Subscale
timeFrame: 6 Months
measure: Diabetes Technology Questionnaire
timeFrame: 6 Months
measure: Problem Areas in Diabetes - Parent (PAID-PR)
timeFrame: 6 Months
measure: Diabetes Family Impact Survey
timeFrame: 6 Months
measure: Satisfaction Questionnaire
timeFrame: 6 Months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Linda DiMeglio, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
citation: Markowitz JT, Volkening LK, Butler DA, Antisdel-Lomaglio J, Anderson BJ, Laffel LM. Re-examining a measure of diabetes-related burden in parents of young people with Type 1 diabetes: the Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR). Diabet Med. 2012 Apr;29(4):526-30. doi: 10.1111/j.1464-5491.2011.03434.x.
citation: Katz ML, Volkening LK, Dougher CE, Laffel LM. Validation of the Diabetes Family Impact Scale: a new measure of diabetes-specific family impact. Diabet Med. 2015 Sep;32(9):1227-31. doi: 10.1111/dme.12689. Epub 2015 Feb 5.
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citation: Wysocki T, Reeves G, Kummer M, Ross J, Yu M. Psychometric validations of the Diabetes Technology Questionnaire; Diabetes. 2015;64(Suppl1): A633.
citation: Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group. A Randomized Clinical Trial Assessing Continuous Glucose Monitoring (CGM) Use With Standardized Education With or Without a Family Behavioral Intervention Compared With Fingerstick Blood Glucose Monitoring in Very Young Children With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):464-472. doi: 10.2337/dc20-1060. Epub 2020 Dec 17.
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