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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: CGM + Family Behavioral Intervention; Device: Standard CGM

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CGM + Family Behavioral Intervention; 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; use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence; Other Names: FBI
Active Comparator: Standard CGM; 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; use of CGM alone to assess CGM adherence
No Intervention: BGM - usual care control group; 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?

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

Collaborators and Investigators

• Sponsor: Jaeb Center for Health Research
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust; Indiana University School of Medicine
• Investigators: Principal Investigator: Linda DiMeglio, MD, MPH, Indiana University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• Marzelli MJ, Mazaika PK, Barnea-Goraly N, Hershey T, Tsalikian E, Tamborlane W, Mauras N, White NH, Buckingham B, Beck RW, Ruedy KJ, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). Neuroanatomical correlates of dysglycemia in young children with type 1 diabetes. Diabetes. 2014 Jan;63(1):343-53. doi: 10.2337/db13-0179. Epub 2013 Oct 29.
• Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.
• Mauras N, Beck R, Xing D, Ruedy K, Buckingham B, Tansey M, White NH, Weinzimer SA, Tamborlane W, Kollman C; Diabetes Research in Children Network (DirecNet) Study Group. A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years. Diabetes Care. 2012 Feb;35(2):204-10. doi: 10.2337/dc11-1746. Epub 2011 Dec 30.
• Barnea-Goraly N, Raman M, Mazaika P, Marzelli M, Hershey T, Weinzimer SA, Aye T, Buckingham B, Mauras N, White NH, Fox LA, Tansey M, Beck RW, Ruedy KJ, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). Alterations in white matter structure in young children with type 1 diabetes. Diabetes Care. 2014 Feb;37(2):332-40. doi: 10.2337/dc13-1388. Epub 2013 Dec 6.
• Sundberg F, Forsander G. Detection and treatment efficacy of hypoglycemic events in the everyday life of children younger than 7 yr. Pediatr Diabetes. 2014 Feb;15(1):34-40. doi: 10.1111/pedi.12057. Epub 2013 Jun 27.
• Rovet JF, Ehrlich RM. The effect of hypoglycemic seizures on cognitive function in children with diabetes: a 7-year prospective study. J Pediatr. 1999 Apr;134(4):503-6. doi: 10.1016/s0022-3476(99)70211-8.
• Rovet JF, Ehrlich RM, Hoppe M. Specific intellectual deficits in children with early onset diabetes mellitus. Child Dev. 1988 Feb;59(1):226-34. doi: 10.1111/j.1467-8624.1988.tb03211.x.
• Ryan CM. Searching for the origin of brain dysfunction in diabetic children: going back to the beginning. Pediatr Diabetes. 2008 Dec;9(6):527-30. doi: 10.1111/j.1399-5448.2008.00481.x. No abstract available.
• Tsalikian E, Fox L, Weinzimer S, Buckingham B, White NH, Beck R, Kollman C, Xing D, Ruedy K; Diabetes Research in Children Network Study Group. Feasibility of prolonged continuous glucose monitoring in toddlers with type 1 diabetes. Pediatr Diabetes. 2012 Jun;13(4):301-7. doi: 10.1111/j.1399-5448.2011.00837.x. Epub 2011 Dec 13.
• 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.
• Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care. 1987 Sep-Oct;10(5):617-21. doi: 10.2337/diacare.10.5.617.
• Wysocki T, Reeves G, Kummer M, Ross J, Yu M. Psychometric validations of the Diabetes Technology Questionnaire; Diabetes. 2015;64(Suppl1): A633.
• 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.
• DiMeglio LA, Kanapka LG, DeSalvo DJ, Anderson BJ, Harrington KR, Hilliard ME, Laffel LM, Tamborlane WV, Van Name MA, Wadwa RP, Willi SM, Woerner S, Wong JC, Miller KM; SENCE Study Group. Time spent outside of target glucose range for young children with type 1 diabetes: a continuous glucose monitor study. Diabet Med. 2020 Aug;37(8):1308-1315. doi: 10.1111/dme.14276. Epub 2020 Mar 17.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: T1DX SENCE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No