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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04186195
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease
Diabetes Mellitus, Type 1

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Psychosocial and Socioeconomic Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Children's type 1 diabetes glycemic control [ Time Frame: Through study completion, an average 5 years ]
    Socioeconomic and psychosocial factors affecting in type 1 diabetes glycemic status in children


Secondary Outcome Measures :
  1. Parents' divorce rate [ Time Frame: Through study completion, an average 5 years ]
    Frequency of parent's divorces in a family with a child with type 1 diabetes

  2. Parent's type 1 diabetes glycemic status [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186195


Contacts
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Contact: Riina Pironetti +358 3 311611 riina.pironetti@pshp.fi
Contact: Päivi Keskinen +358 3 311611 paivi.keskinen@pshp.fi

Sponsors and Collaborators
Tampere University Hospital
Investigators
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Principal Investigator: Marja-Terttu Saha Tampere University

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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT04186195    
Other Study ID Numbers: R19096
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tampere University Hospital:
Glycemic control
Children
Psychosocial and socioeconomic factors
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases