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NCT Number: NCT04427189

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. hypoglycemia rate

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

    number of events of severe hypoglycemia

  2. 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

  3. DKA rate

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

    number of hospitalizations due to DKA

Study contacts

Contact information is provided by the study sponsor or research team.

Bärbel Dr. Aschemeier-Fuchs, PH

CONTACT

[email protected]

+49 511 8115 3342

Olga Prof. Kordonouri, MD

CONTACT

[email protected]

+49 511 8115 3331

Sponsors and collaborators

Lead sponsor

Kinderkrankenhaus auf der Bult

Other

Collaborators

  • SWEET e.V

Registry information

Official study title

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

Acronym: SWEET

Important dates

Study start
2008
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2020
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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