Better Control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Change of HbA1c level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change of HbA1c level
时间窗: through study completion, an average of 1 year, up to 5 years
assessment of the metabolic situation based on the level of HbA1c
次要结局
- 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)
研究者
Olga Kordonouri
Prof. Dr.
Kinderkrankenhaus auf der Bult