Skip to main content
OpenTrials
Completed

NCT Number: NCT01050868

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ulm, 89081, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accu-Chek Combo Kit mg DE/de

Device

Primary outcomes

  1. 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 outcomes

  1. To compare the absolute difference between the SMBG value and the target value between the calculators

    Time frame: 6 hours after meal

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 18, 2010
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.