An interventional study of Automated bolus calculator and Advanced Carbohydrate Counting in Type 1 Diabetes, sponsored by Steno Diabetes Center Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-24.
Sponsored by Steno Diabetes Center Copenhagen · Not applicable, Interventional, and Treatment
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 Accu-Chek Aviva Expert. Additionally, the investigators propose that carbohydrate counting will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose. Finally the investigators hypothesize that the use of Accu-Chek Aviva Expert will lead to fewer hypoglycemic episodes.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 178 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Steno Diabetes Center Copenhagen is the lead sponsor of 113 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Training in advanced carbohydrate counting
Behavioral: Advanced Carbohydrate Counting
Training in advanced carbohydrate counting plus the use of an automated bolus calculator.
Device: Automated bolus calculator · Behavioral: Advanced Carbohydrate Counting
Training in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept.
Also known as: Accu-Chek Aviva Expert, Roche Diagnostics
Training in advanced carbohydrate counting.
Change in HbA1c
Time frame: Baseline, 12 months
Frequency of serious hypoglycemic events
Time frame: Baseline, 12 months
Frequency of glucose below, in or above target 4-8 mmol/l assessed by blinded Continuous Glucose Monitoring 6 days before study start and 6 days before ending the study
Time frame: Baseline, 12 months
Frequency of blood glucose measurements assessed by meter download before randomization and at each visit during the study
Time frame: Baseline, 12 months
Treatment Satisfaction
Measured by Diabetes Treatment Satisfaction Questionnaire
Time frame: Baseline, 12 months
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Steno Diabetes Center Copenhagen →