Better Control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference (SWEET- Registry)

NCT04427189 | Recruiting

• 1 other identifier: SWEET-10
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief 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'. 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.

Conditions

Type 1 Diabetes

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• Change of HbA1c level

  assessment of the metabolic situation based on the level of HbA1c

  through study completion, an average of 1 year, up to 5 years

Secondary Outcomes (3)

• hypoglycemia rate

  through study completion, an average of 1 year, up to 5 years

• Time in Range

  through study completion, an average of 1 year, up to 5 years

• DKA rate

  through study completion, an average of 1 year, up to 5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Diabetes centres worldwide diagnosed with Diabetes mellitus

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kinderkrankenhaus auf der Bult: lead
• SWEET e.V: collaborator

Study Sites (1)

Kinderkrankenhaus auf der Bult

Hanover, Low Saxony, 30173, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 40303253 DERIVED

• 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.

  PMID: 36183869 DERIVED

• 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.

  PMID: 34086503 DERIVED

• 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.

  PMID: 33566729 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Thomas Danne, MD

  Kinderkrankenhaus auf der Bult

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Prof. Kordonouri, MD

CONTACT

+49 511 8115 3331; kordonouri@hka.de

Bärbel Dr. Aschemeier-Fuchs, PH

CONTACT

+49 511 8115 3342; aschemeier@hka.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 11, 2020
• Study Start: April 1, 2008
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

DE (1)