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Completed

NCT Number: NCT03840161

Use of CoG by Patients With Diabetes Mellitus

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.

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Key information

Conditions

Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mills-Penisnsula Medical Center

San Mateo, California, 94596, United States

About this study

The trial starts with a screening and training visit (V1). This is followed by an individual calibration period for the non-invasive device component by means of multiple parallel measurements with the invasive and the noninvasive device component. This will be done by the participants at home. Thereafter, the participants will come to the study site and will ingest a standardized meal (V2). Blood will be drawn for assessment of HbA1c and biochemical safety parameters. During the next 3 hours, 11 fingersticks will be made to obtain capillary blood samples for comparator readings with the two CoG components and with a laboratory reference method (YSI gucose analyzer). The patients will now continue to use the devices at home for three months, but are not allowed to use any CoG result for treatment decisions. In an interim visit after 6 weeks (V3), blood will be drawrn for HbA1c and biochemical safety parameters and three comparison measurements will be made with the CoG device components and the laboratory reference method. At the final visit after 12 weeks (V4), the procedures of the first meal test visit (V2) will be repeated, which conludes that study. In addition, the participants will be asked to complete a device satisfaction questionnaire at V2, V3, and V4.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • 18 years old and above;
  • HbA1c < 10 %
  • Anatomically suitable finger as determined by the clinical investigator and detailed in section 4

Exclusion criteria

  • Does not meet inclusion criteria;
  • 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)

Treatment and study plan

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)

Other names: invasive blood glucose measurement

Primary outcomes

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

    Time frame: Experiment will be performed twice within 3 months

    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

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

    Time frame: Experiment will be performed twice within 3 months

    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

Secondary outcomes

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

    Time frame: 3 months

    Change in HbA1c from baseline after 6 weeks and 12 weeks

  2. Treatment satisfaction questionnaire

    Time frame: 3 months

    Change in device satisfaction questionnaire score after 6 weeks and 12 weeks

Sponsors and collaborators

Lead sponsor

Sciema UG

Other

Collaborators

  • Cnoga Medical Ltd.

Registry information

Official study title

Evaluation of the CNOGA TensorTip COMBO GLUCOMETER (CoG) During Standardized Meal Test and Consecutive Home Use by Patients With Diabetes Mellitus

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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