Study of the Effects of Carbohydrate Counting
The Effect of Carbohydrate Counting and Bolus Calculation Using an Electronic Calculator in Carbohydrate Counting-naïve Persons With Non-optimally Treated Type 1 Diabetes
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJanuary 28, 2014
January 1, 2014
10 months
October 18, 2010
January 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
4 months
Secondary Outcomes (5)
Variation in blood glucose
4 months
Number of hypoglycemic events
4 months
Treatment satisfaction
4 months
Total daily insulin dose
4 months
Weight
4 months
Study Arms (3)
Control group
NO INTERVENTIONParticipants in this arm continues their usual insulin therapy
Carb counting
ACTIVE COMPARATORParticipants in this arm are taught carb counting
Carb counting and bolus calculator
ACTIVE COMPARATORParticipants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator.
Interventions
Eligibility Criteria
You may qualify if:
- Type 1 diabetes
- Diabetes duration at least 12 months
- MDI therapy
- HbA1c 8-10,5% (both included)
You may not qualify if:
- Gastroparesis
- Present or former practice of carbohydrate counting
- Pregnancy or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hvidovre University Hospitallead
- The Danish Council for Strategic Researchcollaborator
- Medtroniccollaborator
- Roche Pharma AGcollaborator
- Novo Nordisk A/Scollaborator
Study Sites (1)
Hvidovre University Hospital
Hvidovre, 2650, Denmark
Related Publications (1)
Schmidt S, Meldgaard M, Serifovski N, Storm C, Christensen TM, Gade-Rasmussen B, Norgaard 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.
PMID: 22344610DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Signe Schmidt, MD
Hvidovre University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 19, 2010
Study Start
October 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 28, 2014
Record last verified: 2014-01