Diabetes Mellitus Type 1
Conditions
Brief summary
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.
Interventions
DEVICEAccu-Chek Combo Kit mg DE/de
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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
Exclusion criteria
* 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 * Pregnant or lactating women * Any known life-threatening disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 6 hours after meal |
Secondary
| Measure | Time frame |
|---|---|
| To compare the absolute difference between the SMBG value and the target value between the calculators | 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 | 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 | 6 hours after meal |
Countries
Germany
Outcome results
None listed