Study of the Effects of Carbohydrate Counting

Hvidovre University Hospital

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01223547

BOLUSCAL

Details and patient eligibility

About

The investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that the metabolic control can be further improved with concurrent use of an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes
• Diabetes duration at least 12 months
• MDI therapy
• HbA1c 8-10,5% (both included)

Exclusion criteria

• Gastroparesis
• Present or former practice of carbohydrate counting
• Pregnancy or nursing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 3 patient groups

Control group

No Intervention group

Description:

Participants in this arm continues their usual insulin therapy

Carb counting

Active Comparator group

Description:

Participants in this arm are taught carb counting

Treatment:

Other: Education

Other: Education

Carb counting and bolus calculator

Active Comparator group

Description:

Participants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator.

Treatment:

Other: Education

Other: Education