NCT02912728: SENCE

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

Completed NA Last updated 5 October 2020

What this trial tests

NA trial testing CGM + Family Behavioral Intervention in Type 1 Diabetes Mellitus in 143 participants. Completed in 30 June 2019.

Timeline

30 January 2017

Primary endpoint
30 June 2019

30 June 2019

Quick facts

Lead sponsor	Jaeb Center for Health Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	supportive care
Enrollment	143
Start date	30 January 2017
Primary completion	30 June 2019
Estimated completion	30 June 2019
Sites	1 location across United States

Drugs / interventions tested

• CGM + Family Behavioral Intervention
• Standard CGM

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

Jaeb Center for Health Research — full company profile →

Who can join

Adults 2 to 7, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Benefits and Barriers of Continuous Glucose Monitoring in Young Children with Type 1 Diabetes.
   Hilliard ME, Levy W, Anderson BJ, Whitehouse AL, et al · · 2019 · cited 101× · PMID 31287721 · DOI 10.1089/dia.2019.0142
2. 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.
   Strategies to Enhance New CGM Use in Early Childhood (SENCE) Study Group. · · 2021 · cited 67× · PMID 33334807 · DOI 10.2337/dc20-1060
3. Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes.
   Welsh JB, Zhang X, Puhr SA, Johnson TK, et al · · 2019 · cited 25× · PMID 30198331 · DOI 10.1177/1932296818798816
4. Time spent outside of target glucose range for young children with type 1 diabetes: a continuous glucose monitor study.
   DiMeglio LA, Kanapka LG, DeSalvo DJ, Anderson BJ, et al · · 2020 · cited 18× · PMID 32096282 · DOI 10.1111/dme.14276
5. Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study.
   Van Name MA, Kanapka LG, DiMeglio LA, DiMeglio LA, et al · · 2023 · cited 14× · PMID 35343269 · DOI 10.1177/19322968221084667
6. Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study): an open-label, multicentre, multinational, randomised cross-over study protocol.
   Fuchs J, Allen JM, Boughton CK, Wilinska ME, et al · · 2021 · cited 8× · PMID 33579766 · DOI 10.1136/bmjopen-2020-042790
7. Twelve-month psychosocial outcomes of continuous glucose monitoring with behavioural support in parents of young children with type 1 diabetes.
   Commissariat PV, DiMeglio LA, Kanapka LG, Laffel LM, et al · · 2023 · cited 7× · PMID 37083018 · DOI 10.1111/dme.15120