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

August 31, 2021 updated by: Thomas Danne, Kinderkrankenhaus auf der Bult

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

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.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Anticipated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

  • Germany
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from Diabetes centres worldwide diagnosed with Diabetes mellitus

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Kinderkrankenhaus auf der Bult

Collaborators

SWEET e.V

Investigators

  • Principal Investigator: Thomas Danne, MD, Kinderkrankenhaus auf der Bult

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2008

Primary Completion (Anticipated)

April 1, 2028

Study Completion (Anticipated)

September 1, 2028

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

June 8, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

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

No

Studies a U.S. FDA-regulated device product

No

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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