Study of the Effects of Carbohydrate Counting

January 26, 2014 updated by: Signe Schmidt, Hvidovre University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Participants in this arm continues their usual insulin therapy
Active Comparator: Carb counting
Participants in this arm are taught carb counting
Other: Education
Participants are taught the principles of carb counting
Other: Education
Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator.
Other Names:
  • The integrated glucose meter and bolus calculator: Aviva Expert, Roche
Active Comparator: Carb counting and bolus calculator
Participants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator.
Other: Education
Participants are taught the principles of carb counting
Other: Education
Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator.
Other Names:
  • The integrated glucose meter and bolus calculator: Aviva Expert, Roche

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 4 months
4 months
Variation in blood glucose
Time Frame: 4 months
Measured by CGM
4 months
Number of hypoglycemic events
Time Frame: 4 months
BG < or = 2.8 and/or unconsciousness
4 months
Treatment satisfaction
Time Frame: 4 months
Questionnaires
4 months
Total daily insulin dose
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Collaborators

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

Investigators

  • Principal Investigator: Signe Schmidt, MD, Hvidovre University Hospital

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

October 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 18, 2010

First Posted (Estimate)

October 19, 2010

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 26, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOLUSCAL

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.

Clinical Trials on Type 1 Diabetes

Clinical Trials on Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe