Use of CoG by Patients With Diabetes Mellitus

NCT03840161 | Completed FDA Device

• 1 other identifier: CNG-NGM-003
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The CNOGA Combo Glucometer (CoG) employs an invasive glucose meter using blood glucose teststrips and requiering a capillary blood sample obtained from a fingerstick and in addition, a non-invasive optical component for prediction of tissue glucose at the fingertip. In this study, participants will use both devices during meal tests and also at home during routine care. The results from the device will be compared to a standard reference method and will be used to determine the accuracy of the two device components.

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus Type 1; Diabetes mellitus Type 2; blood glucose self-testing; non-invasive tissue glucose prediction; optical pain-free glucose testing

Outcome Measures

Primary Outcomes (2)

• CoG accuracy in measuring glucose levels (non-invasively) during a standardized meal experiment.

  Comparison of non-invasive CoG device measurements (tissue glucose in mg/dL) with the results of a standard laboratory reference method (YSI glucose analyzer, blood glucose in mg/dL) by consensus-error grid analysis

  Experiment will be performed twice within 3 months

• CoG accuracy in monitoring glucose levels (invasively) during a standardized meal experiment.

  Comparison of CoG invasive device readings (blood glucose in mg/dL) with the results of a standard laboratory reference method (YSI glucose analyzer, blood glucose in mg/dL) by consensus-error grid analysis

  Experiment will be performed twice within 3 months

Secondary Outcomes (2)

• Impact of the CoG on long-term (three month) glycemic control (HbA1c using standard laboratory procedures) in patients with type 1 and 2 diabetes

  3 months

• Treatment satisfaction questionnaire

  3 months

Interventions

non-invasive tissue glucose prediction DEVICE

Generation of non-invasive and invasive glucose readings for comparison with a standard laboratory reference glucose determination method (YSI glucose analyzer)

Also known as: invasive blood glucose measurement

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diabetes mellitus (type 1 or type 2, any treatment) of other than caucasian origin, who are experienced with performing blood glucose self-testing.

You may qualify if:

• Patients with Type 1 or Type 2 diabetes of Afro-American, Hispanic, or Asian-American origin
• Subjects who are able to provide informed consent (by him/herself or by his/her guardian);
• years old and above;
• HbA1c \< 10 %
• Anatomically suitable finger as determined by the clinical investigator and detailed in section 4

You may not qualify if:

• Subjects requiring dialysis;
• Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars and/or tattoos;
• Pregnancy;
• Nursing mothers;
• Any skin injuries on the measured finger;
• Severe disease conditions (cancer etc.)
• Any condition that may prevent patients from successful participation in the trial (in discretion of the investigator)

Sponsors & Collaborators

• Sciema UG: lead
• Cnoga Medical Ltd.: collaborator

Study Sites (1)

Mills-Penisnsula Medical Center

San Mateo, California, 94596, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Filiz Demircik, PhD

  Sciema UG

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: February 15, 2019
• Study Start: July 16, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: January 18, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)