Diabetes. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: This study is a diagnostic performance evaluation trial designed to assess the clinical performance of a medical device. Within this framework, the “intervention” i
Sponsors
Behbahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Aged 18 years or older Diagnosis of non–insulin-dependent type 2 diabetes mellitus in the primary study participants, established according to the criteria of the American Diabetes Association (ADA) Eligible patients attending the Hospital Diabetes Clinic and the physician’s Private Practice Provision of written informed consent prior to study participation Ability to undergo glucose measurements using the index finger If required, additional volunteers were enrolled to cover specific glucose concentration ranges in accordance with ISO 15197 standards, including healthy non-diabetic volunteers and patients with type 1 diabetes with a documented history of hypoglycemia or hyperglycemia
Exclusion criteria
Exclusion criteria: Age under 18 years Pregnancy or lactation Hematocrit outside the range of 30–55 percent Use of vasoconstrictors, dopamine, procaine, lidocaine, or benzocaine within the past 7 days Administration of intravascular dyes or staining/diluting agents such as methylene blue, indocyanine green, or indigo carmine within the past 7 days Severe cardiovascular disease Hepatic or renal dysfunction Dialysis Severe ketoacidosis Conditions affecting the accuracy of hand/finger measurements (e.g., tremor, Parkinson’s disease, chronic arterial occlusive disease, history of hand or arm surgery, prior arteriovenous fistula surgery, or arterial/venous ostomy) Presence of malignant tumors Alcohol or substance abuse Hemoglobin level below 80 grams per liter Any interfering condition at the tested index finger (e.g., abrasion, wound, raised congenital nevi, scar, tattoo, nail polish, artificial/false nails, tattoo ink, or isolating substances such as dirt, grease, oil, creams, or gels) Mental, visual, or cognitive impairment that interferes with study participation Participation in another clinical trial within the past month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of blood glucose concentration values measured by the non-invasive self-monitoring glucometer that fall within the acceptable error limits defined by the ISO 15197 standard (±15 mg/dL for glucose concentrations <100 mg/dL and ±15% for glucose concentrations =100 mg/dL, relative to the mean venous plasma glucose concentration values measured using the reference method). Timepoint: Day 1 of the study (under fasting and 2-hour postprandial conditions), Day 15 of the study (under fasting and 2-hour postprandial conditions), and Day 30 of the study (under fasting and 2-hour postprandial conditions). Method of measurement: Non-invasive self-monitoring glucometer, clinical diagnostic laboratory analyzer based on the hexokinase or glucose oxidase method (used as the reference method), over-the-counter self-monitoring blood glucose device based on fingerstick capillary blood sampling.;Percentage of blood glucose concentration values measured by the non-invasive self-monitoring glucometer that fall within zones A and B of the Consensus Error Grid (CEG). Timepoint: Day 1 of the study (under fasting and 2-hour postprandial conditions), Day 15 of the study (under fasting and 2-hour postprandial conditions), and Day 30 of the study (under fasting and 2-hour postprandial conditions). Method of measurement: Non-invasive self-monitoring glucometer, clinical diagnostic laboratory analyzer based on the hexokinase or glucose oxidase method (used as the reference method), over-the-counter self-monitoring blood glucose device based on fingerstick capillary blood sampling.;The value of the repeatability coefficient of variation (with a 95% confidence interval) for blood glucose concentration values measured by non-invasive self-monitoring glucometers, for glucose concentrations =100 mg/dL, according to ISO 15197 standard. Timepoint: Day 1 of the study (under fasting and 2-hour postprandial conditions), Day 15 of the study (under fasting and 2-hour postprandial conditions), and | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean Clarity and Usefulness Score of the instructions for use and messages displayed on the non-invasive self-monitoring glucometer. Timepoint: Once, on Day 1 of the study (during the user's first encounter with the non-invasive self-monitoring glucometer). Method of measurement: A structured questionnaire consisting of a series of 5-point Likert scale questions, where the respondent selects their level of agreement with each statement from "Strongly Disagree" to "Strongly Agree".;The percentage of users who, without receiving any assistance or training, are able to correctly and independently perform User Verification processes as per ISO 15197. These verifications include checking system function (System Control) and the correct sequence of procedural steps during or immediately after using the non-invasive self-monitoring glucometer. Timepoint: Once, on Day 1 of the study (during the user's first use of the non-invasive self-monitoring glucometer). Method of measurement: This variable is measured using a structured observer checklist completed by a trained observer, who records the user's success or failure in independently performing two verification actions, "system function check" and "adherence to the correct test sequence," immediately after the first self-test. The result is reported as the percentage of users who successfully completed the actions.;Percentage of users who, during their first independent use of the non-invasive self-monitoring glucometer, do not commit any safety-related use error that leads to a hazardous situation. Timepoint: Once, during the user's first independent use of the non-invasive self-monitoring glucometer (Day 1 of the study). Method of measurement: Measured using a structured usability test observation report form designed according to the requirements of the International Electrotechnical Commission standard IEC 62366-1. A trained evaluator observes the user's performance during all critical tasks and records any use err | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohsen Cheki
Ahvaz University of Medical Sciences
Outcome results
None listed