Happy Bob App in 9-13 Year-old Children

NCT05663606 | Unknown

• 1 other identifier: OUS-2022-028
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Type 1 diabetes; Continuous glucose monitoring; Gamification; Time in Range

Outcome Measures

Primary Outcomes (1)

• TIR

  Change in time in range, 3.9-10 mmol/l (%)

  6 months

Secondary Outcomes (8)

• TBR

  6 months

• TAR

  6 months

• SG

  6 months

• SD

  6 months

• CV

  6 months

Study Arms (2)

Happy Bob Arm

ACTIVE COMPARATOR

Subjects, who are using Happy Bob App in addition to CGM

Combination Product: Happy Bob; Device: CGM

Controls

PLACEBO COMPARATOR

Subjects, who are using CGM only

Device: CGM

Interventions

Happy Bob COMBINATION_PRODUCT

Application, which gives stars when subject reachs Time In Range

Happy Bob Arm

CGM DEVICE

Dexcom CGM

Controls; Happy Bob Arm

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Type 1 diabetes diagnosis more than 6 months ago
• Age 9-13 years
• Prepubertal
• Capability to use Happy Bob -app and continuous glucose monitoring (CGM)

You may not qualify if:

• Psychiatric diagnosis and other conditions, which in the opinion of the investigator would put the participant at risk during the trial.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• DexCom, Inc.: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatric Endocrinologist

Model Details: prospective, randomized, controlled study

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 23, 2022
• Study Start: June 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share