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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

Accu-Chek Combo Kit mg DE/de

Intervention Type DEVICE

Interventions

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Accu-Chek Combo Kit mg DE/de

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No