Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia

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. Identifier: NCT01013402
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : November 13, 2009
Information provided by:
Gulhane School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Hypoglycemia Drug: Human insulin Drug: Human Insulin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Arm Intervention/treatment
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.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01013402

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

Responsible Party: Dr. Alper Sonmez, Gulhane School of Medicine Department of Endocrinology and Metabolism Identifier: NCT01013402     History of Changes
Other Study ID Numbers: GSM-012009
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: November 13, 2009
Last Verified: November 2009

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

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