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OpenTrials
Completed

NCT Number: NCT02084498

Advanced Carbohydrate Counting and Automated Bolus Calculation

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Automated bolus calculator

Device

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

Advanced Carbohydrate Counting

Behavioral

Training in advanced carbohydrate counting.

Primary outcomes

  1. Change in HbA1c

    Time frame: Baseline, 12 months

Secondary outcomes

  1. Frequency of serious hypoglycemic events

    Time frame: Baseline, 12 months

Other outcomes

  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

    Time frame: Baseline, 12 months

  2. Frequency of blood glucose measurements assessed by meter download before randomization and at each visit during the study

    Time frame: Baseline, 12 months

  3. Treatment Satisfaction

    Time frame: Baseline, 12 months

    Measured by Diabetes Treatment Satisfaction Questionnaire

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • Hvidovre University Hospital

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 12, 2014
Registry last updated
Nov 24, 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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