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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01050868
First Posted: January 18, 2010
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention
Diabetes Mellitus Type 1 Device: Accu-Chek Combo Kit mg DE/de

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Device: Accu-Chek Combo Kit mg DE/de

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050868


Locations
Germany
Ulm, Germany, 89081
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Bettina Petersen Roche Diagnostics GmbH / Diabetes Care
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01050868     History of Changes
Other Study ID Numbers: RD000811
First Submitted: January 15, 2010
First Posted: January 18, 2010
Last Update Posted: March 3, 2016
Last Verified: January 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases