Efficacy of Automated Bolus Calculation in Type 2 Diabetes

Hvidovre University Hospital80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Automated bolus calculatorDEVICE

EducationOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hvidovre University Hospital

Hvidovre, Denmark

Outcomes

Primary Outcomes

Change in HbA1c

Time frame: 6 months

Secondary Outcomes

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

Time frame: 6 months

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

Time frame: 6 months

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

Time frame: 6 months

Change in diet habits/diet composition

Assessed by electronic diet recordings

Time frame: 6 months

Change in treatment satisfaction

Using questionnaire

Time frame: 6 months

Data from ClinicalTrials.gov

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