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Search / Trial NCT02546063

Carbohydrate Estimation Supported by the GoCARB System

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Sep 7, 2015

Trial Information

Current as of April 26, 2025

Completed

Keywords

ClinConnect Summary

Background

For individuals with type 1 diabetes (T1D) the current gold standard to evaluate the carbohydrate (CHO) amount of a meal is by carefully weighing its different components and calculating the CHO content using reference nutritional tables. The resulting CHO amount is then used to define the insulin dose needed to avoid an abnormal postprandial glucose profile. Since this is a cumbersome procedure in real life, diabetic individuals often estimate the CHO amount based on their personal experience. Especially for food served on a plate CHO estimates are often significantly over or u...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Type 1 diabetes
  • Minimum age of 18 years old
  • Sensor-augmented pump therapy for at least six months
  • HbA1c levels within the last 4 months ≤ 8.5%
  • Familiar with carbohydrate (CHO) counting (e.g. CHO counting training in the past)
  • Normal insulin sensitivity (reflected by a daily insulin requirement of 0.3-1.0 U/kg body weight)
  • Able to comprehend German or English
  • Written informed consent
  • Exclusion Criteria
  • Relevant diabetic complications
  • Hypoglycemia unawareness
  • More than one episode of severe hypoglycemia as defined by American Diabetes Association in preceding 12 months
  • Pregnancy
  • Relevant psychiatric disorder
  • Active neoplasia
  • Participation in another study
  • Other individuals especially in need of protection (according to the guidelines of the Swiss Academy of Medical Sciences)

About Insel Gruppe Ag, University Hospital Bern

Insel Gruppe AG, the umbrella organization for the University Hospital Bern, is a leading healthcare provider in Switzerland, renowned for its commitment to advancing medical research and patient care. As a key player in clinical trials, Insel Gruppe AG integrates cutting-edge scientific inquiry with clinical excellence, facilitating innovative studies that span a wide range of medical disciplines. The institution prioritizes collaboration with academic partners and industry stakeholders to enhance the understanding of diseases and develop effective treatment options, ultimately aiming to improve patient outcomes and contribute to the global medical community.

Locations

Bern, , Switzerland

Patients applied

0 patients applied

Trial Officials

Christoph Stettler

Principal Investigator

Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

Stavroula Mougiakakou

Principal Investigator

Diabetes Technology Research Group, ARTORG Center for Biomedical Engineering Research, University of Bern

Markus Laimer

Principal Investigator

Division of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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