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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01050868
First received: January 15, 2010
Last updated: May 23, 2013
Last verified: January 2011
History of Changes
  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: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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
None

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050868

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01050868     History of Changes
Other Study ID Numbers: RD000811
Study First Received: January 15, 2010
Last Updated: May 23, 2013
Health Authority: Germany: Regierungspräsidium Tübingen, Baden-Württemberg

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

ClinicalTrials.gov processed this record on May 23, 2013