Advanced Carbohydrate Counting and Automated Bolus Calculation

Type 1 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084498
• Other study ID #: StenoABC
• Status: Completed
• Phase: N/A
• First received: February 24, 2014
• Last updated: November 20, 2014
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Steno Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

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

Behavioral:
• Advanced Carbohydrate Counting
Training in advanced carbohydrate counting.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
Steno Diabetes Center	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Schmidt S, Meldgaard M, Serifovski N, Storm C, Christensen TM, Gade-Rasmussen B, Nørgaard K. Use of an automated bolus calculator in MDI-treated type 1 diabetes: the BolusCal Study, a randomized controlled pilot study. Diabetes Care. 2012 May;35(5):984-90. doi: 10.2337/dc11-2044. Epub 2012 Feb 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Frequency of blood glucose measurements assessed by meter download before randomization and at each visit during the study		Baseline, 12 months	No
Other	Treatment Satisfaction	Measured by Diabetes Treatment Satisfaction Questionnaire	Baseline, 12 months	No
Primary	Change in HbA1c		Baseline, 12 months	No
Secondary	Frequency of serious hypoglycemic events		Baseline, 12 months	Yes