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OpenTrials
Completed

NCT Number: NCT01223547

Study of the Effects of Carbohydrate Counting

The investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that the metabolic control can be further improved with concurrent use of an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.

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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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes
  • Diabetes duration at least 12 months
  • MDI therapy
  • HbA1c 8-10,5% (both included)

Exclusion criteria

  • Gastroparesis
  • Present or former practice of carbohydrate counting
  • Pregnancy or nursing

Treatment and study plan

Education

Other

Participants are taught the principles of carb counting

Primary outcomes

  1. Change in HbA1c

    Time frame: 4 months

Secondary outcomes

  1. Variation in blood glucose

    Time frame: 4 months

    Measured by CGM

  2. Number of hypoglycemic events

    Time frame: 4 months

    BG < or = 2.8 and/or unconsciousness

  3. Treatment satisfaction

    Time frame: 4 months

    Questionnaires

  4. Total daily insulin dose

    Time frame: 4 months

  5. Weight

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Medtronic
  • Novo Nordisk A/S
  • Roche Pharma AG
  • The Danish Council for Strategic Research

Registry information

Official study title

The Effect of Carbohydrate Counting and Bolus Calculation Using an Electronic Calculator in Carbohydrate Counting-naïve Persons With Non-optimally Treated Type 1 Diabetes

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2010
Registry last updated
Jan 28, 2014

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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