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Happy Bob App in 9-13 Year-old Children

NCT05663606 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-30

No results posted yet for this study

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.

Conditions

  • Type1diabetes

Interventions

COMBINATION_PRODUCT

Happy Bob

Application, which gives stars when subject reachs Time In Range

DEVICE

CGM

Dexcom CGM

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Helsinki University Central Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-09-30
Completion
2024-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05663606 on ClinicalTrials.gov