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NCT05663606
Happy Bob App in 9-13 Year-old Children
Conditions: Type1diabetes
Sex: All
Ages: 9 Years – 13 Years
Phase: NA
Enrollment: 40
Sponsor: Helsinki University Central Hospital
Summary
The purpose of the study is to evaluate the effectiveness of the Happy Bob -application on glycemic control in children aged 9-13 years with type 1 diabetes.
Additionally, investigators evaluate the perceived burden on the diabetes treatment to families during the Happy Bob use, compared to conventional treatment (diabetes distress).This is a prospective, randomized, controlled study where primary endpoint is the change in time-in-range (TIR, 3.9-10 mmol/l) after Happy Bob application initiation.
Secondary endpoints are HbA1c, time below range (TBR, <3.9 mmol/l), time above range (TAR, >10 mmol/l), mean sensor glucose (SG), standard deviation of SG, coefficient of variation (CV, SD/SGx100 (%)), number of boluses and diabetes distress evaluated by PAID (Problem Areas In Diabetes for parents and children/youth).
A sample size of 40 subjects (20 in each groups, and assumed drop-out rate of 10%) would provide the trial with 80% power and type 1 error rate of 0.05 with the following assumption: 7% higher TIR during Happy Bob -use compared to conventional treatment with continuous glucose monitoring (CGM), with a standard deviation of 7.5% (based on Happy Bob marketing study).The inclusion criteria are 1) Type 1 diabetes diagnosis more than 6 months ago 2) Age 9-13 years and prepubertal 3) capability to use Happy Bob -app and continuous glucose monitoring (CGM).
The exclusion criteria are psychiatric diagnosis and other conditions, which in the opinion of the investigator would put the participant at risk during the trial.The study includes 6 months study time with 2 standard outpatient clinic visits.
Eligibility Criteria
Inclusion Criteria:Type 1 diabetes diagnosis more than 6 months agoAge 9-13 yearsPrepubertalCapability to use Happy Bob -app and continuous glucose monitoring (CGM)Exclusion Criteria:Psychiatric diagnosis and other conditions, which in the opinion of the investigator would put the participant at risk during the trial.
Source: ClinicalTrials.gov (NCT05663606). StuddyBuddy aggregates publicly available trial information.