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BolusCal2: Efficacy of Automated Bolus Calculation in Type 2 Diabetes

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02887898
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
26
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Automated bolus calculator
  • Other: Education
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Advanced Carbohydrate Counting and Automated Bolus Calculation in Insulin-treated Type 2 Diabetes Patients: The BolusCal2 Study
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Carb counting and bolus calculator

Education in carb counting and the use of an automated bolus calculator

Device: Automated bolus calculator

Other: Education
Placebo Comparator: Carb counting

Education in carb counting and manual calculation of insulin bolus

Other: Education

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c [6 months]

Secondary Outcome Measures

  1. Time spent below, in or above the glucose target 4-10 mmol/l measured by continuous glucose monitoring (CGM) [6 months]

  2. Frequency of blood glucose measurements assessed by meter download before randomization and at each visit [6 months]

  3. Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance) [6 months]

  4. Change in diet habits/diet composition [6 months]

    Assessed by electronic diet recordings

  5. Change in treatment satisfaction [6 months]

    Using questionnaire

Other Outcome Measures

  1. Adherences to bolus calculator use [6 months]

    Using questionnaire

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hvidovre University Hospital Hvidovre Denmark 2650

Sponsors and Collaborators

  • Hvidovre University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merete Bechmann Christensen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT02887898
Other Study ID Numbers:
  • BolusCal2
First Posted:
Sep 2, 2016
Last Update Posted:
Jan 22, 2020
Last Verified:
Jan 1, 2020
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jan 22, 2020