Advanced Carbohydrate Counting and Automated Bolus Calculation

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Advanced Carbohydrate Counting; Device: Automated bolus calculator

• Registration Number: NCT02084498
• Lead Sponsor: Steno Diabetes Center Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-12
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACC	Advanced Carbohydrate Counting	Training in advanced carbohydrate counting
ACC + ABC	Automated bolus calculator	Training in advanced carbohydrate counting plus the use of an automated bolus calculator.
ACC + ABC	Advanced Carbohydrate Counting	Training in advanced carbohydrate counting plus the use of an automated bolus calculator.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline, 12 months

Secondary Outcome Measures

Name	Time	Method
Frequency of serious hypoglycemic events	Baseline, 12 months

Trial Locations

Locations (1)

Steno Diabetes Center; 🇩🇰 Gentofte, Denmark