Comparison of the Management of Post-prandial Hyperglycemia by Multiple Bolus Calculators

Roche

Status

Completed

Conditions

Diabetes Mellitus Type 1

Treatments

Device: Accu-Chek Combo Kit mg DE/de

Study type

Interventional

Funder types

Industry

Identifiers

NCT01050868

RD000811

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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