Study to measure how well the Tensortip Combo Glucometer can measure blood glucose with finger-pricks

Not Applicable

Completed

• Conditions: Accuracy of glucometer in determining blood glucose levels in patients with diabetes mellitus; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN12167086
• Lead Sponsor: CNOGA Medical Ltd.

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29451016 (added 06/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-10-20
• Study Start: 2018-05-24
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Type 1 diabetes or type 2 diabetes or healthy

Exclusion Criteria

1. Not able to perform study at the discretion of investigator
2. Uptake of high doses of vitamin C
3. Uptake of acetylsalicylic acid
4. Inability to operate device

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The bias between the results obtained with the invasive TensorTip CoG component from the mean reference results will be calculated and the data pairs will be analyzed by means of a consensus-error-grid analysis according to Parkes et al., 2000.

Secondary Outcome Measures

Name	Time	Method
The bias between the results obtained with the non-invasive TensorTip CoG component from the mean reference results will be calculated and the data pairs will be analyzed by means of a consensus-error-grid analysis according to Parkes et al., 2000