Type 1 DiabetesFr1dolinNCT02750527
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
An observational study of Type 1 Diabetes and Familial Hypercholesterolemia, run by Kinderkrankenhaus auf der Bult.
Trial summary
This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6 years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9) routine check-ups and any voluntary visits to the pediatricians office. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Familial Hypercholesterolemia
- How many people
- 13,049 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2020
- 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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: According to the Federal Statistical Office (31.12.2014) 320.000 children in the age of 2 to 6 years are living in lower Saxony, Germany. Based on the Fr1da experience a participation rate of 25-35 % is expected. The current estimated prevalence of FH und T1D of 1:300 leads to the expected number of 450 newly identified cases of FH and T1D in each case in the period of 18 months. Additional subjects with FH would be identified by cascade screening.
Who may be able to join
- Children living in Lower Saxony (primary residence)
- Age between 2 and 6 years (both included)
- Written consent by at least one parent / legal representative
- Willingness to deliver 200 µl of capillary blood
- Willingness to complete a questionnaire
- Willingness to participate to the follow-up visits
Who cannot join
- none
About this study
This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6 years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9) routine check-ups and any voluntary visits to the pediatricians office.
Read the detailed description
The Fr1dolin-Study will be presented to the parents of ca. 320,000 children living in Lower Saxony, Germany. The recruitment of subjects, collection of written consent, the capillary blood sample and the screening questionnaire will be done by the registered pediatricians in their local medical practices.
After study enrolment 200 µl of capillary blood are be taken from the subject and are sent pseudo-anonymized to the lab. LDL-C and the diabetes-associated antibodies are identified. Based on the results a second blood sample will be required. In case of pre-type-1 diabetes or signs for a familial hypercholesterolemia the pediatrician will be informed. He will contact the parents and discuss the further procedure in cooperation with the study center.
In case of a positive result by measuring diabetes-related antibodies and LDL-C the goal of this trial is to advise and educate the families appropriate and to treat them if necessary. In addition families should have the possibility to participate in prevention trials.
All data will be registered in a study database.
Follow-up pre-type 1 diabetes:
During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years or up to 6 months after the clinical onset of type 1 diabetes.
Follow-up familial hypercholesterolemia:
During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years.
- Conditions
- Type 1 Diabetes, Familial Hypercholesterolemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hyperlipoproteinemia Type II
What is being measured
The primary outcome is the main question the study is designed to answer.
number of familial hypercholesterolemia or pre-type-1-diabetes
identification of patients/ families with familial hypercholesterolemia or pre-type-1 diabetes
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 13,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kinderkrankenhaus auf der Bult
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Kordonouri, Kinderkrankenhaus auf der Bult
- Investigators
- Olga Kordonouri, MD, Principal investigator, Kinder- und Jugendkrankenhaus AUF DER BULT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750527
- Sponsor's protocol ID
- H-Fr1dolin-01
- Acronym
- Fr1dolin
- Status last verified
- Jun 2021
- First submitted
- 21 Apr 2016
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
- ClinicalTrials.gov ID
- NCT02750527
- Acronym / sponsor ID
- Fr1dolin / H-Fr1dolin-01
- Conditions
- Type 1 Diabetes, Familial Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,049 participants (actual)
- Lead sponsor
- Kinderkrankenhaus auf der BultUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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.
This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6 years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9) routine check-ups and any voluntary visits to the pediatricians office.
Detailed description
The Fr1dolin-Study will be presented to the parents of ca. 320,000 children living in Lower Saxony, Germany. The recruitment of subjects, collection of written consent, the capillary blood sample and the screening questionnaire will be done by the registered pediatricians in their local medical practices.
After study enrolment 200 µl of capillary blood are be taken from the subject and are sent pseudo-anonymized to the lab. LDL-C and the diabetes-associated antibodies are identified. Based on the results a second blood sample will be required. In case of pre-type-1 diabetes or signs for a familial hypercholesterolemia the pediatrician will be informed. He will contact the parents and discuss the further procedure in cooperation with the study center.
In case of a positive result by measuring diabetes-related antibodies and LDL-C the goal of this trial is to advise and educate the families appropriate and to treat them if necessary. In addition families should have the possibility to participate in prevention trials.
All data will be registered in a study database.
Follow-up pre-type 1 diabetes:
During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years or up to 6 months after the clinical onset of type 1 diabetes.
Follow-up familial hypercholesterolemia:
During the first year, follow-up will be performed after 6 and 12 months and thereafter annually until the age of 12 years.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- According to the Federal Statistical Office (31.12.2014) 320.000 children in the age of 2 to 6 years are living in lower Saxony, Germany. Based on the Fr1da experience a participation rate of 25-35 % is expected. The current estimated prevalence of FH und T1D of 1:300 leads to the expected number of 450 newly identified cases of FH and T1D in each case in the period of 18 months. Additional subjects with FH would be identified by cascade screening.
Key inclusion criteria (6 listed)
- Children living in Lower Saxony (primary residence)
- Age between 2 and 6 years (both included)
- Written consent by at least one parent / legal representative
- Willingness to deliver 200 µl of capillary blood
- Willingness to complete a questionnaire
Key exclusion criteria (1 listed)
- none
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
number of familial hypercholesterolemia or pre-type-1-diabetes
Time frame: 18 month
identification of patients/ families with familial hypercholesterolemia or pre-type-1 diabetes
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 16 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Olga Kordonouri, MD principal investigator
Kinder- und Jugendkrankenhaus AUF DER BULT
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Familial Hypercholesterolemia, run by Kinderkrankenhaus auf der Bult.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. 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 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
number of familial hypercholesterolemia or pre-type-1-diabetes (time frame: 18 month). 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 16 Jun 2021.