Bolus Insulin Card Calculator Randomised Controlled Study

John Hunter Children's Hospital

Status: Unknown

Conditions: Type 1 Diabetes

Treatments: Device: ezy-BICC dose calculation card; Other: Fixed dose

Study type: Interventional

Funder types: Other

Identifiers

NCT00748137

06/04/26/5.01

Details and patient eligibility

About

In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to the use of variable size meals and insulin doses determined with a bolus insulin calculation card.

Enrollment: 150 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 11 - 18 years old
• Currently using indvidual subcutaneous injections (not CSII)

Exclusion criteria

• HbA1c > 9.5%
• Serious illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Fixed dose

Active Comparator group

Description:

Fixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin.

Treatment:

Other: Fixed dose

ezy-BICC dose calculation card

Experimental group

Description:

variable meal size with variable aspart insulin dose determined with use of individualised dose calculation card. Detemir basal insulin.

Treatment:

Device: ezy-BICC dose calculation card