Study of the Effects of Carbohydrate Counting

Type 1 Diabetes Clinical Trial

Official title:

The Effect of Carbohydrate Counting and Bolus Calculation Using an Electronic Calculator in Carbohydrate Counting-naïve Persons With Non-optimally Treated Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223547
• Other study ID #: BOLUSCAL
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: January 26, 2014
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: January 2014
• Source: Hvidovre University Hospital
• 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 an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes

• Diabetes duration at least 12 months

• MDI therapy

• HbA1c 8-10,5% (both included)

Exclusion Criteria:

• Gastroparesis

• Present or former practice of carbohydrate counting

• Pregnancy or nursing

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Education
Participants are taught the principles of carb counting
• Education
Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (5)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Medtronic, Novo Nordisk A/S, Roche Pharma AG, The Danish Council for Strategic Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		4 months	No
Secondary	Variation in blood glucose	Measured by CGM	4 months	No
Secondary	Number of hypoglycemic events	BG < or = 2.8 and/or unconsciousness	4 months	Yes
Secondary	Treatment satisfaction	Questionnaires	4 months	No
Secondary	Total daily insulin dose		4 months	No
Secondary	Weight		4 months	No