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Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia

Primary Purpose

Hypoglycemia

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Human insulin
Human Insulin
Sponsored by
Gulhane School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypoglycemia focused on measuring Hypoglycemia, Home Blood Glucose Monitoring, Subjects are being investigated for the integrity of, pituitary-adrenal functions by insulin hypoglycemia test.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gulhane School of Medicine Department of Endocrinology and Metabolism

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

volunteers for insulin hypoglycemia test

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 12, 2009
Last Updated
November 12, 2009
Sponsor
Gulhane School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01013402
Brief Title
Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gulhane School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
Keywords
Hypoglycemia, Home Blood Glucose Monitoring, Subjects are being investigated for the integrity of, pituitary-adrenal functions by insulin hypoglycemia test.

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
volunteers for insulin hypoglycemia test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Human insulin
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Human Insulin
Intervention Description
0.1U/kg IV pulse.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Gulhane School of Medicine Department of Endocrinology and Metabolism
City
Ankara
ZIP/Postal Code
06018
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
8941473
Citation
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.
Results Reference
background
PubMed Identifier
11446542
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
3677983
Citation
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.
Results Reference
background

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Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia

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