Advanced Carbohydrate Counting and Automated Bolus Calculation

A Randomized Controlled Large Study of Flexible Intensified Insulin Therapy (FIIT) With Carbohydrate Counting (CHC) Versus FIIT With Carbohydrate Counting and Automated Bolus Calculation (ABC)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02084498

Enrollment

178

Registered

2014-03-12

Start date

2012-09-30

Completion date

2014-11-30

Last updated

2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Automated bolus calculator (ABC), Advanced carbohydrate counting (ACC), Patient empowerment

Brief summary

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.

Interventions

DEVICEAutomated bolus calculator

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

BEHAVIORALAdvanced Carbohydrate Counting

Training in advanced carbohydrate counting.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c	Baseline, 12 months

Secondary

Measure	Time frame
Frequency of serious hypoglycemic events	Baseline, 12 months

Other

Measure	Time frame	Description
Frequency of glucose below, in or above target 4-8 mmol/l assessed by blinded Continuous Glucose Monitoring 6 days before study start and 6 days before ending the study	Baseline, 12 months	—
Frequency of blood glucose measurements assessed by meter download before randomization and at each visit during the study	Baseline, 12 months	—
Treatment Satisfaction	Baseline, 12 months	Measured by Diabetes Treatment Satisfaction Questionnaire

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026