Strategies to Enhance New CGM Use in Early Childhood (SENCE)
NCT ID: NCT02912728
Last Updated: 2020-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
143 participants
INTERVENTIONAL
2017-01-30
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM
NCT00760526
A Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes
NCT02258373
Assessing Continuous Glucose Monitors in Healthy Children
NCT00069602
Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth
NCT03815552
Tolerability, Acceptance, and Utility of Intermittent CGM Use in Youth With Prediabetes
NCT05505565
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
CGM + Family Behavioral Intervention
use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence
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.
Standard CGM
use of CGM alone to assess CGM adherence
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CGM + Family Behavioral Intervention
use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence
Standard CGM
use of CGM alone to assess CGM adherence
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
2 Years
7 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Indiana University School of Medicine
OTHER
Jaeb Center for Health Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Linda DiMeglio, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Indiana
Indianapolis, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
T1DX SENCE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.