Psychosocial Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT04186195
• Lead Sponsor: Tampere University Hospital

Brief Summary

The aim of the study is to research psychosocial and socioeconomic factors among families that might affect glycemic control in children and adolescent with type 1 diabetes mellitus. These factors might be: living conditions, structure of the family, socioeconomic status, divorces and parent's own glycemic control status (if parent's type 1 diabetes mellitus is present in the family).

Detailed Description

This study is going to clarify if there are some socioeconomical or psychosocial factors that might influence child's type 1 diabetes mellitus glycemic control. Study population consists of 300-350 diabetic children aged 1-16 years who have diabetic controls at Tampere University Hospital and their families. Required information is going to be collected with 2 questionnaires, wich families are kindly asked to fill in.

Study Timeline

• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-04
• Study Start: 2020-11-03
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

Type 1 diabetic children aged 1-16 years and their parents. Patient's and parents' willingness to participate

Exclusion Criteria

Type 1 diabetes duration under 1 year. Difficulties to understand written finnish.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Children's type 1 diabetes glycemic control	Through study completion, an average 5 years	Socioeconomic and psychosocial factors affecting in type 1 diabetes glycemic status in children

Secondary Outcome Measures

Name	Time	Method
Parent's type 1 diabetes glycemic status	Through study completion, an average 5 years	Possible parent's own type 1 diabetes glycemic status correlation with a child's type 1 diabetes glycemic control
Parents' divorce rate	Through study completion, an average 5 years	Frequency of parent's divorces in a family with a child with type 1 diabetes

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland