Advanced Carbohydrate Counting and Automated Bolus Calculation

Steno Diabetes Centers

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: Advanced Carbohydrate Counting; Device: Automated bolus calculator

Study type: Interventional

Funder types: Other

Identifiers

NCT02084498

StenoABC

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 Accu-Chek Aviva Expert. Additionally, the investigators propose that carbohydrate counting will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose. Finally the investigators hypothesize that the use of Accu-Chek Aviva Expert will lead to fewer hypoglycemic episodes.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 1 diabetes
• Age >18 years
• Diabetes duration more than 12 months
• Multiple Daily Injections therapy (fast acting analog for meals; long acting analog as basal)
• HbA1c between 8.0% and 11.3%

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

ACC

Active Comparator group

Description:

Training in advanced carbohydrate counting

Treatment:

Behavioral: Advanced Carbohydrate Counting

ACC + ABC

Experimental group

Description:

Training in advanced carbohydrate counting plus the use of an automated bolus calculator.

Treatment:

Device: Automated bolus calculator

Behavioral: Advanced Carbohydrate Counting