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

Type 1 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912728
• Other study ID #: T1DX SENCE
• Status: Completed
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2020
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• CGM + Family Behavioral Intervention
use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence

Device:
• Standard CGM
use of CGM alone to assess CGM adherence

Locations

Country	Name	City	State
United States	Indiana	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	Indiana University School of Medicine, The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Rovet JF, Ehrlich RM, Hoppe M. Specific intellectual deficits in children with early onset diabetes mellitus. Child Dev. 1988 Feb;59(1):226-34. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Topp CW, Østergaard SD, Søndergaard 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. Review. — View Citation

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. — View Citation

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. — View Citation

Wysocki T, Reeves G, Kummer M, Ross J, Yu M. Psychometric validations of the Diabetes Technology Questionnaire; Diabetes. 2015;64(Suppl1): A633.

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HbA1c at 6-months	A secondary outcome is to compare HbA1c at 6-months, adjusted for baseline.	6 Months
Secondary	% HbA1c <7.0%		6 Months
Secondary	% HbA1c <7.5%		6 Months
Secondary	% with relative reduction in HbA1c >=10%		6 Months
Secondary	% with absolute reduction in HbA1c >=0.5%		6 Months
Secondary	% with absolute reduction in HbA1c >=1%		6 Months
Secondary	% with absolute reduction in HbA1c >=1% or HbA1c <7.0%		6 Months
Secondary	Mean glucose		6 Months
Secondary	Glucose variability measured by coefficient of variation		6 Months
Secondary	% time >180 mg/dl		6 Months
Secondary	% time >250 mg/dl		6 Months
Secondary	% time >300 mg/dl		6 Months
Secondary	Area under the curve 180 mg/dl		6 Months
Secondary	High blood glucose index (HBGI)		6 Months
Secondary	% time <54 mg/dl		6 Months
Secondary	% time <60 mg/dl		6 Months
Secondary	% time <70 mg/dl		6 Months
Secondary	Area over the curve 70 mg/dl		6 Months
Secondary	Low blood glucose index (LBGI)		6 Months
Secondary	Hypoglycemic events (using <54 mg/dl)		6 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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