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: June 10, 2014
Last verified: January 2011
  Purpose

This prospective, non-randomized, non-controlled, interventional study will dete rmine whether the Roche automated bolus caclulator (ABC) reduces post-meal hyper glycemia better than the competitor's ABC without causing significant hypoglycem ia.


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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 10, 2014
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 August 21, 2014