Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia

This study has been completed.
Sponsor:
Information provided by:
Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT01013402
First received: November 12, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

The purpose of this study is to compare the accuracies and the capillary and venous comparabilities of five different home glucose monitors; Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart in an adult population.


Condition Intervention Phase
Hypoglycemia
Drug: Human insulin
Drug: Human Insulin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Phase IV Study to Compare the Accuracy and Precission of Five Different Home Glucose Monitors;Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart

Resource links provided by NLM:


Further study details as provided by Gulhane School of Medicine:

Enrollment: 51
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: volunteers for insulin hypoglycemia test
None of the subjects had diabetes mellitus or any other metabolic diseases. They were not taking any medicine and they did not have anemia or polycythemia. Also none of the patients had any condition causing hypoxia or any compromise in peripheral circulation.
Drug: Human insulin
The test was performed in the morning after an overnight fasting and the patients remained supine during the procedure. Two intravenous lines in both arms were established before the procedure. Venous blood was obtained for serum glucose before regular insulin (0.1 U/kg ) is injected and 30 and 45 minutes thereafter. If adequate hypoglycemia was not achieved at this period, a second dose of regular insulin (0.05U/kg) was injected intravenously. In subjects who had not reached the aimed hypoglycemia levels, the test was performed in another day with a higher initial insulin dosage (0.2U/kg).
Drug: Human Insulin
0.1U/kg IV pulse.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being under investigation for pituitary- adrenal functions

Exclusion Criteria:

  • Diabetes mellitus or any other chronic metabolic disease
  • Taking medicine for any reason
  • Anemia
  • Polyctemia
  • Compromised circulation
  • Hypoxia
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01013402

Locations
Turkey
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
  More Information

Publications:
Responsible Party: Dr. Alper Sonmez, Gulhane School of Medicine Department of Endocrinology and Metabolism
ClinicalTrials.gov Identifier: NCT01013402     History of Changes
Other Study ID Numbers: GSM-012009
Study First Received: November 12, 2009
Last Updated: November 12, 2009
Health Authority: Turkey: Ethics Committee

Keywords provided by Gulhane School of Medicine:
Hypoglycemia
Home Blood Glucose Monitoring
Subjects are being investigated for the integrity of
pituitary-adrenal functions by insulin hypoglycemia test.

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014