OneLook: Non invasive blood glucose measurement (pilot study)

ISRCTN	ISRCTN68716188
DOI	https://doi.org/10.1186/ISRCTN68716188
Secondary identifying numbers	5296

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 05/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Dan Daly
Scientific

London Road
Reading
RG1 5AQ
United Kingdom

Study information

Study design	Non-randomised interventional and observational process of care clinical laboratory study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	GP practice
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	DRN208
Study objectives	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(s)	National Research Ethics Service - Berkshire Research Ethics Committee approved on the 3rd June 2008 (ref: 08/H0505/70)
Health condition(s) or problem(s) studied	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
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 study start date	11/08/2008
Completion date	23/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	Planned Sample Size: 30; UK Sample Size: 30
Key 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
Key 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
Date of first enrolment	11/08/2008
Date of final enrolment	23/03/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

London Road

Reading
RG1 5AQ
United Kingdom

Sponsor information

Lein Applied Diagnostics Ltd (UK)
Industry

London Road
Reading
RG1 5AQ
United Kingdom

Website	http://www.lein-ad.com/
"ROR"	https://ror.org/02nwjvq32

Funders

Funder type

Government

NHS Innovations (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration Results presented as a poster entitled "OneLook Non-invasive Blood Glucose Measurement" at the International Diabetes Federation conference in Montreal in October 2009.
IPD sharing plan

Editorial Notes

05/08/2021: Details of poster results have been moved from the publication list to the publication and dissemination plan.