Advanced Carbohydrate Counting and Automated Bolus Calculation

N/ACompletedNCT02084498

Steno Diabetes Center Copenhagen178 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Type 1 Diabetes

Interventions

Automated bolus calculatorDEVICE

Training in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept.

Advanced Carbohydrate CountingBEHAVIORAL

Training in advanced carbohydrate counting.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Steno Diabetes Center

Gentofte Municipality, Denmark

Outcomes

Primary Outcomes

Change in HbA1c

Time frame: Baseline, 12 months

Secondary Outcomes

Frequency of serious hypoglycemic events

Time frame: Baseline, 12 months

Data from ClinicalTrials.gov

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