Study of the Effects of Carbohydrate Counting

This study has been completed.
Sponsor:
Collaborators:
The Danish Council for Strategic Research
Medtronic
Roche Pharma AG
Novo Nordisk A/S
Information provided by (Responsible Party):
Signe Schmidt, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01223547
First received: October 18, 2010
Last updated: January 26, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Other: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Variation in blood glucose [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Measured by CGM

  • Number of hypoglycemic events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    BG < or = 2.8 and/or unconsciousness

  • Treatment satisfaction [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Questionnaires

  • Total daily insulin dose [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Participants in this arm continues their usual insulin therapy
Active Comparator: Carb counting
Participants in this arm are taught carb counting
Other: Education
Participants are taught the principles of carb counting
Active Comparator: Carb counting and bolus calculator
Participants in this arm are taught carb counting and are provided with an integrated glucose meter and bolus calculator.
Other: Education
Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator.
Other Name: The integrated glucose meter and bolus calculator: Aviva Expert, Roche

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223547

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
The Danish Council for Strategic Research
Medtronic
Roche Pharma AG
Novo Nordisk A/S
Investigators
Principal Investigator: Signe Schmidt, MD Hvidovre University Hospital
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Signe Schmidt, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01223547     History of Changes
Other Study ID Numbers: BOLUSCAL
Study First Received: October 18, 2010
Last Updated: January 26, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Carbohydrate counting
Insulin bolus calculation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014