Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments automated bolus calculator, advanced carbohydrate counting
Sponsor Steno Diabetes Center
Collaborator Hvidovre University Hospital
Start date September 2012
End date November 2014
Trial size 196 participants
Trial identifier NCT02084498, StenoABC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Training in advanced carbohydrate counting
advanced carbohydrate counting
Training in advanced carbohydrate counting.
(Experimental)
Training in advanced carbohydrate counting plus the use of an automated bolus calculator.
automated bolus calculator Accu-Chek Aviva Expert, Roche Diagnostics
Training in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept.
advanced carbohydrate counting
Training in advanced carbohydrate counting.

Primary Outcomes

Measure
Change in HbA1c
time frame: Baseline, 12 months

Secondary Outcomes

Measure
Frequency of serious hypoglycemic events
time frame: Baseline, 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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)
Principal investigator Eva E Hommel, MD, DMSc
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Steno Diabetes Center.