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

Hoffmann-La Roche24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Type 1

Interventions

Accu-Chek Combo Kit mg DE/deDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Ulm, Germany

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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