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

Hvidovre University Hospital1 site in 1 country80 target enrollmentSeptember 2016

ConditionsType 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Hvidovre University Hospital
Enrollment: 80
Locations: 1
Primary Endpoint: Change in HbA1c
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

November 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hvidovre University Hospital

Responsible Party

Principal Investigator

Merete Bechmann Christensen

Hvidovre University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: 6 months

Secondary Outcomes

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