Efficacy of Automated Bolus Calculation in Type 2 Diabetes (BolusCal2)

January 21, 2020 updated by: Merete Bechmann Christensen, Hvidovre University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Carb counting and bolus calculator
Education in carb counting and the use of an automated bolus calculator
Other: Education
Device: Automated bolus calculator
PLACEBO_COMPARATOR: Carb counting
Education in carb counting and manual calculation of insulin bolus
Other: Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time spent below, in or above the glucose target 4-10 mmol/l measured by continuous glucose monitoring (CGM)
Time Frame: 6 months
6 months
Frequency of blood glucose measurements assessed by meter download before randomization and at each visit
Time Frame: 6 months
6 months
Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance)
Time Frame: 6 months
6 months
Change in diet habits/diet composition
Time Frame: 6 months
Assessed by electronic diet recordings
6 months
Change in treatment satisfaction
Time Frame: 6 months
Using questionnaire
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherences to bolus calculator use
Time Frame: 6 months
Using questionnaire
6 months

Collaborators and Investigators

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

Sponsor

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 (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

November 1, 2018

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (ESTIMATE)

September 2, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BolusCal2

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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