Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5296
Study information
Scientific title
A non-randomised interventional clinical laboratory study to assess whether Lein's novel non-invasive glucose measurement technique offers a viable alternative to the current invasive capillary blood glucose solution
Acronym
DRN208
Study hypothesis
To assess whether Lein's novel non-invasive glucose measurement technique offers a viable alternative to the current invasive capillary blood glucose solution.
The purpose of this trial was to check for correlation between measured results taken from Lein's meter, the current leading capillary glucose meters and a gold standard venous blood laboratory measurement.
Ethics approval
National Research Ethics Service - Berkshire Research Ethics Committee approved on the 3rd June 2008 (ref: 08/H0505/70)
Study design
Non-randomised interventional and observational process of care clinical laboratory study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Diabetes Research Network; Subtopic: Both; Disease: Device studies
Intervention
Volunteers were tested over a period of 4 hours with blood glucose readings taken with conventional finger stick meters and a gold standard venous blood meter every 15 minutes. Eye data was also collected every 15 minutes in order to enable the investigating team to compare the readings. The volunteers were provided with a sandwich lunch part way through the trial in order to produce a change in their blood glucose levels.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Measurements were performed at specific points in time that compared various meters. The results were analysed using multi-level and mixed models in the statistical software package "R".
Secondary outcome measures
No secondary outcome measures
Overall trial start date
11/08/2008
Overall trial end date
23/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18 to 75 years, male only
2. Type 2 diabetes for at least 3 months
3. Able and willing to do fingerprick blood glucose testing
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned Sample Size: 30; UK Sample Size: 30
Participant exclusion criteria
1. Age less than 18 and greater than 75 years
2. Significant renal impairment defined as a serum creatinine above 200 µg/ml
3. History of severe depression or mental instability
4. People with type 1 diabetes
5. Coexistent other serious illness
6. Pregnancy
7. Epilepsy
8. Known human immunodeficiency virus (HIV), hepatitis B, C or other blood borne infection
9. Previous laser refractive surgery or cataract surgery
10. An ocular refractive error that is not between -5 and +5 dioptres
11. Astigmatism over 1 dioptre
12. Glaucoma
13. Cataract
14. Colour blindness
Recruitment start date
11/08/2008
Recruitment end date
23/03/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
London Road
Reading
RG1 5AQ
United Kingdom
Sponsor information
Organisation
Lein Applied Diagnostics Ltd (UK)
Sponsor details
London Road
Reading
RG1 5AQ
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
NHS Innovations (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results presented as a poster entitled OneLook Non-invasive Blood Glucose Measurement at the International Diabetes Federation conference in Montreal in October 2009.