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Advanced Carbohydrate Counting and Automated Bolus Calculation

Sponsor
Steno Diabetes Center Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT02084498
Collaborator
Hvidovre University Hospital (Other)
178
Enrollment
1
Location
2
Arms
26
Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Automated bolus calculator
  • Behavioral: Advanced Carbohydrate Counting
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
178 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

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.

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

    • Behavioral: Advanced Carbohydrate Counting
    Training in advanced carbohydrate counting.

    Outcome Measures

    Primary Outcome Measures

    1. Change in HbA1c [Baseline, 12 months]

    Secondary Outcome Measures

    1. Frequency of serious hypoglycemic events [Baseline, 12 months]

    Other Outcome Measures

    1. 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 [Baseline, 12 months]

    2. Frequency of blood glucose measurements assessed by meter download before randomization and at each visit during the study [Baseline, 12 months]

    3. Treatment Satisfaction [Baseline, 12 months]

      Measured by Diabetes Treatment Satisfaction Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Steno Diabetes Center Gentofte Denmark 2820

    Sponsors and Collaborators

    • Steno Diabetes Center Copenhagen
    • Hvidovre University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Eva Hommel, Senior Consultant, Steno Diabetes Center Copenhagen
    ClinicalTrials.gov Identifier:
    NCT02084498
    Other Study ID Numbers:
    • StenoABC
    First Posted:
    Mar 12, 2014
    Last Update Posted:
    Nov 24, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Eva Hommel, Senior Consultant, Steno Diabetes Center Copenhagen
    Automated bolus calculator (ABC)
    Advanced carbohydrate counting (ACC)
    Patient empowerment
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Nov 24, 2014