Advanced Carbohydrate Counting and Automated Bolus Calculation

November 20, 2014 updated by: Eva Hommel, Steno Diabetes Center Copenhagen

A Randomized Controlled Large Study of Flexible Intensified Insulin Therapy (FIIT) With Carbohydrate Counting (CHC) Versus FIIT With Carbohydrate Counting and Automated Bolus Calculation (ABC)

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 Accu-Chek Aviva Expert. Additionally, the investigators propose that carbohydrate counting will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose. Finally the investigators hypothesize that the use of Accu-Chek Aviva Expert will lead to fewer hypoglycemic episodes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

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
      • Gentofte, Denmark, 2820
        • Steno Diabetes center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with type 1 diabetes
  • Age >18 years
  • Diabetes duration more than 12 months
  • Multiple Daily Injections therapy (fast acting analog for meals; long acting analog as basal)
  • HbA1c between 8.0% and 11.3%

Exclusion Criteria:

  • Present or former practice of carbohydrate counting
  • Gastroparesis
  • 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
Active Comparator: ACC
Training in advanced carbohydrate counting
Behavioral: Advanced Carbohydrate Counting
Training in advanced carbohydrate counting.
Experimental: ACC + ABC
Training in advanced carbohydrate counting plus the use of an automated bolus calculator.
Behavioral: Advanced Carbohydrate Counting
Training in advanced carbohydrate counting.
Device: Automated bolus calculator
Training in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept.
Other Names:
  • Accu-Chek Aviva Expert, Roche Diagnostics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: Baseline, 12 months
Baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of serious hypoglycemic events
Time Frame: Baseline, 12 months
Baseline, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of glucose below, in or above target 4-8 mmol/l assessed by blinded Continuous Glucose Monitoring 6 days before study start and 6 days before ending the study
Time Frame: Baseline, 12 months
Baseline, 12 months
Frequency of blood glucose measurements assessed by meter download before randomization and at each visit during the study
Time Frame: Baseline, 12 months
Baseline, 12 months
Treatment Satisfaction
Time Frame: Baseline, 12 months
Measured by Diabetes Treatment Satisfaction Questionnaire
Baseline, 12 months

Collaborators and Investigators

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

Sponsor

Steno Diabetes Center Copenhagen

Collaborators

Hvidovre University Hospital

Investigators

  • Principal Investigator: Eva E Hommel, MD, DMSc, Steno Diabetes Center Copenhagen

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

September 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StenoABC

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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