Comparison of the Management of Post-prandial Hyperglycemia by Multiple Bolus Calculators
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This prospective, non-randomized, non-controlled, interventional study will determine whether the Roche automated bolus caclulator (ABC) reduces post-meal hyperglycemia better than the competitor's ABC without causing significant hypoglycemia.
To compare the difference between the self-monitoring blood glucose (SMBG) value achieved at 6 hours after meals with induced post-prandial hyperglycemia and the mean target value of 110 mg/dL. Target post-prandial range is 80-140 mg/dL. [ Time Frame: 6 hours after meal ]
Secondary Outcome Measures
To compare the absolute difference between the SMBG value and the target value between the calculators [ Time Frame: 6 hours after meal ]
To compare theto compare the relative difference (multiplied by 100) between the SMBG value and the target value between the calculators [ Time Frame: 6 hours after meal ]
To compare the absolute relative difference (RAD, multiplied by 100) between the SMBG value and the target value between the calculators [ Time Frame: 6 hours after meal ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Subjects >/= 18 years at screening
Type 1 diabetics currently using an insulin pump for management of their diabetes and have been on a pump for at least at least 6 months prior to the screening visit
Subjects have to use a fast acting analog insulin
HbA1c = 9% (measured with DCA 2000)
Willing to perform periods of intensive blood glucose (BG) monitoring for up to 21 days prior to the study (~10 tests per day) with skipped meals and testmeals
Willing to use the 3 different bolus calculators during the course of the study
Willing to undergo planned hyperglycemia
Willing to perform high frequency BG monitoring (> 20 / day) during the experiment
Type 2 Diabetes
Manifest severe late complications of diabetes (e.g. severe macro- or microangiopathy, severe neuropathy, severe retinopathy and/or severe nephropathy)
Current addiction to alcohol or substances of abuse