- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427189
Better Control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference (SWEET- Registry) (SWEET)
Better Control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Thomas Prof. Danne, MD
- Phone Number: +49 511 8115 3330
- Email: danne@hka.de
Study Contact Backup
- Name: Bärbel Dr. Aschemeier-Fuchs, PH
- Phone Number: +49 511 8115 3342
- Email: aschemeier@hka.de
Study Locations
-
-
Low Saxony
-
Hanover, Low Saxony, Germany, 30173
- Recruiting
- Kinderkrankenhaus auf der Bult
-
Contact:
- Thomas Danne, MD
- Phone Number: +49 511 8115 3330
- Email: danne@hka.de
-
Contact:
- Bärbel Aschemeier-Fuchs, PH
- Phone Number: +49 511 81153342
- Email: aschemeier@hka.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
through study completion, an average of 1 year, up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hypoglycemia rate
Time Frame: through study completion, an average of 1 year, up to 5 years
|
number of events of severe hypoglycemia
|
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
|
percentage of CGM values between 70-180 mg/dl
|
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
|
number of hospitalizations due to DKA
|
through study completion, an average of 1 year, up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Danne, MD, Kinderkrankenhaus auf der Bult
Publications and helpful links
General Publications
- Limbert 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.
- Danne 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.
- Gerhardsson 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SWEET-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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