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

Type 1 Diabetes Clinical Trial

— SWEET  

Official title:

Better Control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04427189
• Other study ID #: SWEET-10
• Status: Recruiting
• Start date: April 2008
• Est. completion date: September 2028

Study information

• Verified date: May 2024
• Source: Kinderkrankenhaus auf der Bult
• Contact: Olga Prof. Kordonouri, MD
• Phone: +49 511 8115 3331
• Email: kordonouri[@]hka.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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'. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: September 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Diabetes mellitus (as diagnosed clinically)

2. Males and females of all Ages, but with a focus on pediatric care

3. Provision of informed consent from participant and all legal representatives prior to any study specific procedures

Exclusion Criteria:

1. no diabetes

2. no consent,

3. 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

Locations

Country	Name	City	State
Germany	Kinderkrankenhaus auf der Bult	Hanover	Low Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Kinderkrankenhaus auf der Bult	SWEET e.V

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	hypoglycemia rate	number of events of severe hypoglycemia	through study completion, an average of 1 year, up to 5 years
Secondary	Time in Range	percentage of CGM values between 70-180 mg/dl	through study completion, an average of 1 year, up to 5 years
Secondary	DKA rate	number of hospitalizations due to DKA	through study completion, an average of 1 year, up to 5 years