Diabetes Mellitus, Type 1NCT04186195
Psychosocial Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 1, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 191 participants
- Where
- 1 siteFinland
- Study dates
- 3 Nov 2020to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
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.
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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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial and Socioeconomic Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
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).
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Glycemic control, Children, Psychosocial and socioeconomic factors
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's type 1 diabetes glycemic control
Socioeconomic and psychosocial factors affecting in type 1 diabetes glycemic status in children
Measured: Through study completion, an average 5 years
Secondary outcomes (2)
Parents' divorce rate
Frequency of parent's divorces in a family with a child with type 1 diabetes
Measured: Through study completion, an average 5 years
Parent's type 1 diabetes glycemic status
Possible parent's own type 1 diabetes glycemic status correlation with a child's type 1 diabetes glycemic control
Measured: Through study completion, an average 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start3 Nov 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marja-Terttu Saha, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186195
- Sponsor's protocol ID
- R19096
- Status last verified
- May 2022
- First submitted
- 15 Nov 2019
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial and Socioeconomic Factors Affecting Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04186195
- Acronym / sponsor ID
- R19096
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Glycemic control, Children, Psychosocial and socioeconomic factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Parents' divorce rate
Time frame: Through study completion, an average 5 years
Parent's type 1 diabetes glycemic status
Time frame: Through study completion, an average 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marja-Terttu Saha principal investigator
Tampere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's type 1 diabetes glycemic control (time frame: Through study completion, an average 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.