OneLook: Non invasive blood glucose measurement (pilot study)
| ISRCTN | ISRCTN68716188 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68716188 |
| Protocol serial number | 5296 |
| Sponsor | Lein Applied Diagnostics Ltd (UK) |
| Funder | NHS Innovations (UK) |
- 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
Scientific
London Road
Reading
RG1 5AQ
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-randomised interventional and observational process of care clinical laboratory study |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) |
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". |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 23/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
London Road
Reading
RG1 5AQ
United Kingdom
RG1 5AQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/08/2021: Details of poster results have been moved from the publication list to the publication and dissemination plan.
