HypoglycemiaPhase 4NCT01013402
Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia
A Phase 4 study testing Human insulin in people with Hypoglycemia, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Human insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2008to Aug 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being under investigation for pituitary- adrenal functions
Who cannot join
- Diabetes mellitus or any other chronic metabolic disease
- Taking medicine for any reason
- Anemia
- Polyctemia
- Compromised circulation
- Hypoxia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, 06018
About this study
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
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
- Being tested
- Human insulin
- Keywords
- Hypoglycemia, Home Blood Glucose Monitoring, Subjects are being investigated for the integrity of, pituitary-adrenal functions by insulin hypoglycemia test.
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human insulinDrug
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).
Human InsulinDrug
0.1U/kg IV pulse.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Human insulin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013402
- Sponsor's protocol ID
- GSM-012009
- Status last verified
- Nov 2009
- First submitted
- 12 Nov 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8941473Funk 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.
PubMed 11446542Clinical 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
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.
PubMed 3677983
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01013402
- Acronym / sponsor ID
- GSM-012009
- Conditions
- Hypoglycemia
- Keywords
- Hypoglycemia, Home Blood Glucose Monitoring, Subjects are being investigated for the integrity of, pituitary-adrenal functions by insulin hypoglycemia test.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers for insulin hypoglycemia test | Experimental | Drug: Human insulinNone 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Being under investigation for pituitary- adrenal functions
Key exclusion criteria (6 listed)
- Diabetes mellitus or any other chronic metabolic disease
- Taking medicine for any reason
- Anemia
- Polyctemia
- Compromised circulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human insulinThe 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 | volunteers for insulin hypoglycemia test |
| Human Insulin0.1U/kg IV pulse. | Drug | volunteers for insulin hypoglycemia test |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
- Background: PubMed 8941473Trajanoski 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.
- Background: PubMed 11446542Funk 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.
- BackgroundClinical 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: PubMed 3677983Clarke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human insulin in people with Hypoglycemia, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01013402, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2009.