Translating Biometric Data Into Blood Glucose Levels

Study Overview
=================
Brief Summary
-----------------
This study is designed to assist with the development of a first, truly non-invasive technology for blood glucose monitoring, which will have the potential to eliminate the need for painful finger pricking or expensive continuous blood glucose monitor use. The purpose of this study is to collect biometric data, such as bioimpedance (how well the body impedes electric current flow), from participants who are living with type 2 diabetes. A proof-of-concept prototype (non-invasive continuous glucose monitor; NI-CGM) will be used to collect this biometric data. The data will then be used to develop and refine a computer model that can be used to predict blood glucose levels (BGLs). Individuals with diabetes experience a great range of blood BGLs throughout their daily life and activities, therefore it is essential to gather biometric data corresponding to this large range to build a computer model, to ensure model reliability.

Detailed Description
-----------------
The study will be conducted over a two-week period where the participants are required to wear the prototype, that will continuously collect the biometric data. Participants are required to use this device together with two existing commercially available blood glucose meters that are considered management routine for diabetes (an Abbott FreeStyle Libre and an Accu-Chek® Mobile), throughout the duration of the study. The majority of the study is carried out independently, by the participants, where they wear the prototype throughout their daily life and activities. The data collected from the non-invasive custom-built device and the existing blood glucose meters will be used to develop a computer model that will allow for blood glucose levels to be predicted, over time. The study will not interfere with any of the participants' diabetes management plans provided to them, by their regular doctor, under regular care, such as medications, diet and current use of blood glucose monitoring. It is hypothesised that the bioimoedance data collected using the non-invasive prototype device, in conjunction with existing devices used in diabetes management, will enable the development of a computer model that allows for blood glucose levels to be predicted in people with type 2 diabetes.

Official Title
-----------------
Non-invasive Monitoring to Translate the Biometric Data of Participants With Diabetes Into Blood Glucose Levels

Conditions
-----------------
Diabetes Type 2

Intervention / Treatment
-----------------
* Device: Opuz NICGM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 - 70 years Physician diagnosis of Type 2 diabetes Haemoglobin A1c (HbA1c) range between 7 - 10% Body mass index between 20 - 40 Regularly eats 3 meals per day (breakfast, lunch, and dinner) Technologically literate (e.g. able to use Apps, smart phones) Able to commit to attending the Sponsor site Able to commit to wearing a non-invasive, custom-built device through most daily activities Currently self-monitoring their BGL and able to commit to taking measurements at least 6 times per day Proficiency in reading and writing in English Exclusion Criteria: Currently on insulin therapy (other than long-acting insulin therapy) Currently pregnant, pregnant in the last 6 months, or planning a pregnancy Currently breastfeeding Current smoker Any other confounding major disease or condition as deemed appropriate by investigator, determined by review of medical history and/or patient reported medical history Clinically unstable or rapidly progressing diabetic retinopathy, neuropathy, and/or frequent nausea, bloating or vomiting, sever gastroesophageal reflux, or early satiety. Multiple medications (taking more than 10 medications is often an indicator of having multiple major comorbidities which is an exclusion criteria. Furthermore, we want to exclude potential multiple drug interactions with blood glucose levels which may impact results of study) Currently on active curative treatments for cancer Currently receiving systemic glucocorticoid therapy Using lipid-lowering medication at a dose that has not been stable for the past 3 months History of reactions to alcohol wipes, antiseptics, or adhesives (isobornyl acrylate which is the adhesive used for attachment of Freestyle Libre sensors and may cause contact dermatitis) Using an insulin pump Pacemaker fitted Fasting C-peptide levels below 0.5 ng/mL or above 2.0 ng/mL Has had an episode of diabetic ketoacidosis in the past 6 months Has had an episode of severe hypoglycemia within the past 6 months Currently unstable blood glucose control Receiving dialysis treatment Has had a blood transfusion or severe blood loss within the past 3 months Unwilling to self-monitor their BGL (at least 6 measurement, daily) Currently participating in another clinical study Known to the Investigators Other investigator-determined criteria making participants unsuitable for participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opuz NICGM<br>Participants will be provided with one non-invasive, custom-built prototype device (study device), which they will use throughout their day-to-day life/activities over the study period. | Device: Opuz NICGM<br>* A wearable and non-invasive prototype device that allows for measurement of bioimpedance data with the aim to help develop a mathematical model to predict blood glucose levels.<br>* Other names: Opuz Ring;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generation of a predictive models for determining blood glucose levels | Performance of computer models for blood glucose level estimation using collected bioimpedance spectroscopy data. | at 14 days post introduction of intervention | 
| Validation of predictive model for determining blood glucose levels | Performance of predictive models will be evaluated using the consensus error grid. Mean Absolute Relative Difference (MARD) and Consensus Error Grid (CEG) distribution. | at 14 days post introduction of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-invasive, Blood Glucose Levels, Monitoring