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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 1
• Intervention / Treatment: Device: Accu-Chek Combo Kit mg DE/de

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany, 89081

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Device: Accu-Chek Combo Kit mg DE/de

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Bettina Petersen, Roche Diagnostics GmbH / Diabetes Care

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 15, 2010
• First Submitted That Met QC Criteria: January 15, 2010
• First Posted (Estimate): January 18, 2010

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RD000811