Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia

NCT01013402 | Completed Phase 4

• 1 other identifier: GSM-012009
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoglycemia

Keywords

Hypoglycemia; Home Blood Glucose Monitoring; Subjects are being investigated for the integrity of; pituitary-adrenal functions by insulin hypoglycemia test.

Study Arms (1)

volunteers for insulin hypoglycemia test

EXPERIMENTAL

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

Interventions

Human Insulin DRUG

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).

volunteers for insulin hypoglycemia test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being under investigation for pituitary- adrenal functions

You may not qualify if:

• Diabetes mellitus or any other chronic metabolic disease
• Taking medicine for any reason
• Anemia
• Polyctemia
• Compromised circulation
• Hypoxia

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gulhane School of Medicine Department of Endocrinology and Metabolism

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (4)

• Trajanoski Z, Brunner GA, Gfrerer RJ, Wach P, Pieber TR. Accuracy of home blood glucose meters during hypoglycemia. Diabetes Care. 1996 Dec;19(12):1412-5. doi: 10.2337/diacare.19.12.1412.

  PMID: 8941473 BACKGROUND

• Funk DL, Chan L, Lutz N, Verdile VP. Comparison of capillary and venous glucose measurements in healthy volunteers. Prehosp Emerg Care. 2001 Jul-Sep;5(3):275-7. doi: 10.1080/10903120190939788.

  PMID: 11446542 BACKGROUND

• Clinical and Laboratory Standards Institute: Point-of-Care Glucose Testing in Acute and Chronic Care Facilities: Approved Guideline, 2nd ed. CLSI Document C30-A2. Wayne,PA: Clinical and Laboratory Standards Institute, 2002

  BACKGROUND

• Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987 Sep-Oct;10(5):622-8. doi: 10.2337/diacare.10.5.622.

  PMID: 3677983 BACKGROUND

MeSH Terms

Conditions

Hypoglycemia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 13, 2009
• Study Start: December 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 13, 2009

Record last verified: 2009-11

Locations

TU (1)