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Completed

NCT Number: NCT02887898

Efficacy of Automated Bolus Calculation in Type 2 Diabetes

The investigators hypothesize that non-optimal basal-bolus insulin treated patients with type 2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use of an automated bolus calculator. Additionally, the investigators propose that this intervention will lead to improvement in patient related outcomes.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

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 2 diabetes > 1 year
  • Age 18 years or older
  • HbA1C > 64 mmol/mol (8.0 %)
  • Treatment with multiple daily insulin injections (basal and prandial insulin) ≥ 6 months
  • GAD-antibody negative
  • Naïve to bolus calculators

Exclusion criteria

  • Pregnancy or breast feeding
  • Gastroparesis
  • Severe nephropathy (eGFR<30 mL/min/1,73 m2)
  • Use of sulfonylurea

Treatment and study plan

Automated bolus calculator

Device

Education

Other

Primary outcomes

  1. Change in HbA1c

    Time frame: 6 months

Secondary outcomes

  1. Time spent below, in or above the glucose target 4-10 mmol/l measured by continuous glucose monitoring (CGM)

    Time frame: 6 months

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

    Time frame: 6 months

  3. Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance)

    Time frame: 6 months

  4. Change in diet habits/diet composition

    Time frame: 6 months

    Assessed by electronic diet recordings

  5. Change in treatment satisfaction

    Time frame: 6 months

    Using questionnaire

Other outcomes

  1. Adherences to bolus calculator use

    Time frame: 6 months

    Using questionnaire

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Efficacy of Advanced Carbohydrate Counting and Automated Bolus Calculation in Insulin-treated Type 2 Diabetes Patients: The BolusCal2 Study

Acronym: BolusCal2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 2, 2016
Registry last updated
Jan 22, 2020

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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