NCT04186195

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

November 3, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

November 15, 2019

Last Update Submit

May 16, 2022

Conditions

Diabetes Mellitus, Type 1

Keywords

Glycemic controlChildrenPsychosocial and socioeconomic factors

Outcome Measures

Primary Outcomes (1)

  • Children's type 1 diabetes glycemic control

    Socioeconomic and psychosocial factors affecting in type 1 diabetes glycemic status in children

    Through study completion, an average 5 years

Secondary Outcomes (2)

  • Parents' divorce rate

    Through study completion, an average 5 years

  • Parent's type 1 diabetes glycemic status

    Through study completion, an average 5 years

Study Arms (1)

Diabetic children aged 1-16 years and their families

Diabetic children aged 1-16 years and their families. A child's disease duration must be over 1 year so that possible remission period is over.

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Type 1 diabetic children aged 1-16 years followed at Tampere University Hospital and their parents . Child's disease duration minimum 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33100, Finland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Marja-Terttu Saha

    Tampere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2019

First Posted

December 4, 2019

Study Start

November 3, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

FI(1)