Study of the Effects of Carbohydrate Counting

Not Applicable

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT01223547
• Lead Sponsor: Hvidovre University Hospital

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 an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-26
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	4 months

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction	4 months	Questionnaires
Weight	4 months
Variation in blood glucose	4 months	Measured by CGM
Number of hypoglycemic events	4 months	BG \< or = 2.8 and/or unconsciousness
Total daily insulin dose	4 months

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark