Type 1 DiabetesSWEETNCT04427189
Better Control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference (SWEET- Registry)
An observational study of Type 1 Diabetes, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
Trial summary
SWEET-REGISTRY is a multi center, investigator initiated registry in patients with diabetes. SWEET' is an acronym derived from 'Better control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference'. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 100,000 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Sep 2028
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from Diabetes centres worldwide diagnosed with Diabetes mellitus
Who may be able to join
- Diabetes mellitus (as diagnosed clinically)
- Males and females of all Ages, but with a focus on pediatric care
- Provision of informed consent from participant and all legal representatives prior to any study specific procedures
Who cannot join
- no diabetes
- no consent,
- Patient who, in the judgment of the Investigator, is found to be unlikely to comply with the protocol, or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Kinderkrankenhaus auf der Bult
Hanover, Low Saxony, 30173
Olga Kordonouri, MD, +49 511 8115 3331, kordonouri@hka.de
Bärbel Aschemeier-Fuchs, PH, +49 511 81153342, aschemeier@hka.de
About this study
Official title: Better Control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference
SWEET-REGISTRY is a multi center, investigator initiated registry in patients with diabetes. SWEET' is an acronym derived from 'Better control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference'. Having the vision of equal quality care for all children with diabetes the mission of SWEET is to harmonize care to optimize outcomes of children with diabetes worldwide. Initiated with support of the EU Public Health Program in 2008 the SWEET group has over 10 years of experience in creating and sustaining a high quality professional network based on agreed standards of care, criteria for certification, international guidelines and quality control. While originally focusing on the European region, SWEET is currently expanding and has received increasingly global attention, with centers across different continents including Asia, Africa, North and South-America. SWEET extracts wherever possible the data from existing data collection sources and following longitudinally unselected clinical populations of all pediatric diabetes patients as an ongoing measure of benchmarking and a quality control cycle as well as a resource for scientific studies and collaborative research. The SWEET registry was approved by the ethical committee of Hannover Medical School and is associated with the AUF DER BULT Diabetes Centre for Children and Adolescents, Hannover, Germany, which coordinates the SWEET collaboration. Each center has to meet specific entry criteria showing diabetes expertise and compliance with the International Society for Pediatric and Adolescent Diabetes (ISPAD) clinical practice guidelines. The local institutional review boards of the participating centers approved the pseudonymized data collection.
Read the detailed description
The SWEET-Registry is a prospective evaluation of the effectiveness of multidisciplinary treatment approaches of international pediatric diabetes centers.The hypothesis is that a collaboration of pediatric diabetes centers will improve the situation for children with diabetes ensuring that all children have the right to participate fully in all the experiences of childhood and adolescence, regardless of whether they have diabetes and wherever they live. Also it could reduce the effects of accelerated vascular ageing imposed by the diabetic state and provide the basis for a long-term participation in professional and family life without or with delayed debilitating long-term diabetes complications.
SWEET is a real-world study. Therefore the treatment decisions are made by the patient with diabetes and the local treatment team.
The SWEET database combines data from distinct sources. Data is collected locally through clinical databases, electronic health record systems, the standardized SWEET-DPV-documentation software (https://sweet.zibmt.uni-ulm.de/software.php) or centers download data from existing longitudinal registries. Twice yearly, data are transmitted to the central database hosted by the Institute of Epidemiology and Medical Biometry, ZIBMT, Ulm University, Ulm, Germany. The prospectively collected data is then combined into a common database. Inconsistent/improbability or missing data is reported back to the centers for correction. Data is then aggregated into an anonymized, cumulative database used for clinical research, scientific analysis, and nationwide benchmarking.
- Conditions
- Type 1 Diabetes
- Keywords
- Pediatric
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbA1c level
assessment of the metabolic situation based on the level of HbA1c
Measured: through study completion, an average of 1 year, up to 5 years
Secondary outcomes (3)
hypoglycemia rate
number of events of severe hypoglycemia
Measured: through study completion, an average of 1 year, up to 5 years
Time in Range
percentage of CGM values between 70-180 mg/dl
Measured: through study completion, an average of 1 year, up to 5 years
DKA rate
number of hospitalizations due to DKA
Measured: through study completion, an average of 1 year, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study startApr 2008
- Primary completionApr 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Kinderkrankenhaus auf der Bult
- Sponsor type
- University, hospital or other
- Collaborators
- SWEET e.V
- Responsible party
- Principal investigator, Olga Kordonouri, Kinderkrankenhaus auf der Bult
- Investigators
- Thomas Danne, MD, Principal investigator, Kinderkrankenhaus auf der Bult
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427189
- Sponsor's protocol ID
- SWEET-10
- Acronym
- SWEET
- Status last verified
- Oct 2024
- First submitted
- 28 May 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chobot A, Eckert AJ, Biester T, Corathers S, Covinhas A, de Beaufort C, Imane Z, Kim J, Malatynska A, Moravej H, Pokhrel S, Skinner T, Study Group S. Psychological Care for Children and Adolescents with Diabetes and Patient Outcomes: Results from the International Pediatric Registry SWEET. Pediatr Diabetes. 2023 Jun 2;2023:8578231. doi: 10.1155/2023/8578231. eCollection 2023.
PubMed 40303253Limbert C, Lanzinger S, deBeaufort C, Iotova V, Pelicand J, Prieto M, Schiaffini R, Sumnik Z, Pacaud D; SWEET Study Group. Diabetes-related antibody-testing is a valuable screening tool for identifying monogenic diabetes - A survey from the worldwide SWEET registry. Diabetes Res Clin Pract. 2022 Oct;192:110110. doi: 10.1016/j.diabres.2022.110110. Epub 2022 Sep 30.
PubMed 36183869Danne T, Lanzinger S, de Bock M, Rhodes ET, Alonso GT, Barat P, Elhenawy Y, Kershaw M, Saboo B, Scharf Pinto M, Chobot A, Dovc K. A Worldwide Perspective on COVID-19 and Diabetes Management in 22,820 Children from the SWEET Project: Diabetic Ketoacidosis Rates Increase and Glycemic Control Is Maintained. Diabetes Technol Ther. 2021 Sep;23(9):632-641. doi: 10.1089/dia.2021.0110. Epub 2021 Aug 18.
PubMed 34086503Gerhardsson P, Schwandt A, Witsch M, Kordonouri O, Svensson J, Forsander G, Battelino T, Veeze H, Danne T. The SWEET Project 10-Year Benchmarking in 19 Countries Worldwide Is Associated with Improved HbA1c and Increased Use of Diabetes Technology in Youth with Type 1 Diabetes. Diabetes Technol Ther. 2021 Jul;23(7):491-499. doi: 10.1089/dia.2020.0618. Epub 2021 Feb 26.
PubMed 33566729
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference
- ClinicalTrials.gov ID
- NCT04427189
- Acronym / sponsor ID
- SWEET / SWEET-10
- Conditions
- Type 1 Diabetes
- Keywords
- Pediatric
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Kinderkrankenhaus auf der BultUniversity, hospital or other
- Collaborators
- SWEET e.V
- Study start
- Apr 2008 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 11 Jun 2020 (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.
SWEET-REGISTRY is a multi center, investigator initiated registry in patients with diabetes. SWEET' is an acronym derived from 'Better control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference'. Having the vision of equal quality care for all children with diabetes the mission of SWEET is to harmonize care to optimize outcomes of children with diabetes worldwide. Initiated with support of the EU Public Health Program in 2008 the SWEET group has over 10 years of experience in creating and sustaining a high quality professional network based on agreed standards of care, criteria for certification, international guidelines and quality control. While originally focusing on the European region, SWEET is currently expanding and has received increasingly global attention, with centers across different continents including Asia, Africa, North and South-America. SWEET extracts wherever possible the data from existing data collection sources and following longitudinally unselected clinical populations of all pediatric diabetes patients as an ongoing measure of benchmarking and a quality control cycle as well as a resource for scientific studies and collaborative research. The SWEET registry was approved by the ethical committee of Hannover Medical School and is associated with the AUF DER BULT Diabetes Centre for Children and Adolescents, Hannover, Germany, which coordinates the SWEET collaboration. Each center has to meet specific entry criteria showing diabetes expertise and compliance with the International Society for Pediatric and Adolescent Diabetes (ISPAD) clinical practice guidelines. The local institutional review boards of the participating centers approved the pseudonymized data collection.
Detailed description
The SWEET-Registry is a prospective evaluation of the effectiveness of multidisciplinary treatment approaches of international pediatric diabetes centers.The hypothesis is that a collaboration of pediatric diabetes centers will improve the situation for children with diabetes ensuring that all children have the right to participate fully in all the experiences of childhood and adolescence, regardless of whether they have diabetes and wherever they live. Also it could reduce the effects of accelerated vascular ageing imposed by the diabetic state and provide the basis for a long-term participation in professional and family life without or with delayed debilitating long-term diabetes complications.
SWEET is a real-world study. Therefore the treatment decisions are made by the patient with diabetes and the local treatment team.
The SWEET database combines data from distinct sources. Data is collected locally through clinical databases, electronic health record systems, the standardized SWEET-DPV-documentation software (https://sweet.zibmt.uni-ulm.de/software.php) or centers download data from existing longitudinal registries. Twice yearly, data are transmitted to the central database hosted by the Institute of Epidemiology and Medical Biometry, ZIBMT, Ulm University, Ulm, Germany. The prospectively collected data is then combined into a common database. Inconsistent/improbability or missing data is reported back to the centers for correction. Data is then aggregated into an anonymized, cumulative database used for clinical research, scientific analysis, and nationwide benchmarking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from Diabetes centres worldwide diagnosed with Diabetes mellitus
Key inclusion criteria (3 listed)
- Diabetes mellitus (as diagnosed clinically)
- Males and females of all Ages, but with a focus on pediatric care
- Provision of informed consent from participant and all legal representatives prior to any study specific procedures
Key exclusion criteria (3 listed)
- no diabetes
- no consent,
- Patient who, in the judgment of the Investigator, is found to be unlikely to comply with the protocol, or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data
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
Change of HbA1c level
Time frame: through study completion, an average of 1 year, up to 5 years
assessment of the metabolic situation based on the level of HbA1c
3 secondary outcomes
hypoglycemia rate
Time frame: through study completion, an average of 1 year, up to 5 years
Time in Range
Time frame: through study completion, an average of 1 year, up to 5 years
DKA rate
Time frame: through study completion, an average of 1 year, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40303253Chobot A, Eckert AJ, Biester T, Corathers S, Covinhas A, de Beaufort C, Imane Z, Kim J, Malatynska A, Moravej H, Pokhrel S, Skinner T, Study Group S. Psychological Care for Children and Adolescents with Diabetes and Patient Outcomes: Results from the International Pediatric Registry SWEET. Pediatr Diabetes. 2023 Jun 2;2023:8578231. doi: 10.1155/2023/8578231. eCollection 2023.
- Derived from this study: PubMed 36183869Limbert C, Lanzinger S, deBeaufort C, Iotova V, Pelicand J, Prieto M, Schiaffini R, Sumnik Z, Pacaud D; SWEET Study Group. Diabetes-related antibody-testing is a valuable screening tool for identifying monogenic diabetes - A survey from the worldwide SWEET registry. Diabetes Res Clin Pract. 2022 Oct;192:110110. doi: 10.1016/j.diabres.2022.110110. Epub 2022 Sep 30.
- Derived from this study: PubMed 34086503Danne T, Lanzinger S, de Bock M, Rhodes ET, Alonso GT, Barat P, Elhenawy Y, Kershaw M, Saboo B, Scharf Pinto M, Chobot A, Dovc K. A Worldwide Perspective on COVID-19 and Diabetes Management in 22,820 Children from the SWEET Project: Diabetic Ketoacidosis Rates Increase and Glycemic Control Is Maintained. Diabetes Technol Ther. 2021 Sep;23(9):632-641. doi: 10.1089/dia.2021.0110. Epub 2021 Aug 18.
- Derived from this study: PubMed 33566729Gerhardsson P, Schwandt A, Witsch M, Kordonouri O, Svensson J, Forsander G, Battelino T, Veeze H, Danne T. The SWEET Project 10-Year Benchmarking in 19 Countries Worldwide Is Associated with Improved HbA1c and Increased Use of Diabetes Technology in Youth with Type 1 Diabetes. Diabetes Technol Ther. 2021 Jul;23(7):491-499. doi: 10.1089/dia.2020.0618. Epub 2021 Feb 26.
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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.
Thomas Danne, MD principal investigator
Kinderkrankenhaus auf der Bult
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 Type 1 Diabetes, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olga Prof. Kordonouri, MD (+49 511 8115 3331, kordonouri@hka.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HbA1c level (time frame: through study completion, an average of 1 year, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04427189, which also lists 4 linked publications.
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 15 Oct 2024.