Back to resultsStudy of the Effects of Carbohydrate Counting
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Education
Education
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Carbohydrate counting, Insulin bolus calculation
Eligibility Criteria
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
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control group
Carb counting
Carb counting and bolus calculator
Arm Description
Participants in this arm continues their usual insulin therapy
Participants in this arm are taught carb counting
Participants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator.
Outcomes
Primary Outcome Measures
Change in HbA1c
Secondary Outcome Measures
Variation in blood glucose
Measured by CGM
Number of hypoglycemic events
BG < or = 2.8 and/or unconsciousness
Treatment satisfaction
Questionnaires
Total daily insulin dose
Weight
Full Information
NCT ID
NCT01223547
First Posted
October 18, 2010
Last Updated
January 26, 2014
Sponsor
Hvidovre University Hospital
Collaborators
The Danish Council for Strategic Research, Medtronic, Roche Pharma AG, Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT01223547
Brief Title
Study of the Effects of Carbohydrate Counting
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
The Danish Council for Strategic Research, Medtronic, Roche Pharma AG, Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Carbohydrate counting, Insulin bolus calculation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in this arm continues their usual insulin therapy
Arm Title
Carb counting
Arm Type
Active Comparator
Arm Description
Participants in this arm are taught carb counting
Arm Title
Carb counting and bolus calculator
Arm Type
Active Comparator
Arm Description
Participants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Participants are taught the principles of carb counting
Intervention Type
Other
Intervention Name(s)
Education
Other Intervention Name(s)
The integrated glucose meter and bolus calculator: Aviva Expert, Roche
Intervention Description
Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator.
Primary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Variation in blood glucose
Description
Measured by CGM
Time Frame
4 months
Title
Number of hypoglycemic events
Description
BG < or = 2.8 and/or unconsciousness
Time Frame
4 months
Title
Treatment satisfaction
Description
Questionnaires
Time Frame
4 months
Title
Total daily insulin dose
Time Frame
4 months
Title
Weight
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe Schmidt, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
22344610
Citation
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.
Results Reference
derived
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Study of the Effects of Carbohydrate Counting
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