Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
26/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Dan Daly

ORCID ID

Contact details

London Road
Reading
RG1 5AQ
United Kingdom

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 measures

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

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

http://www.lein-ad.com/

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

Results - basic reporting

Publication summary

Results presented as a poster entitled “OneLook – Non-invasive Blood Glucose Measurement” at the International Diabetes Federation conference in Montreal in October 2009.

Publication citations

Additional files

Editorial Notes