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

Hvidovre University Hospital

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: Education; Device: Automated bolus calculator

Study type: Interventional

Funder types: Other

Identifiers

NCT02887898

BolusCal2

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Carb counting and bolus calculator

Active Comparator group

Description:

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

Treatment:

Device: Automated bolus calculator

Other: Education

Carb counting

Placebo Comparator group

Description:

Education in carb counting and manual calculation of insulin bolus

Treatment:

Other: Education