Exploration of a new glucose sensor as part of the AP

Sensor for Measuring glucose levels for a bihormonal fully closed loop: Accuracy and Reliability Trial (SMART 2) - SMART2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58187

Enrollment

Registered

2025-09-23

Start date

2026-01-05

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus type 1, Diabetes Type 1 Diabetes

Interventions

The Inreda CGM sensor is part of a CGM system designed to monitor glucose levels in patients with type 1 or type 2 diabetes, aged 18 years or older.&nbsp

The sensor measures glucose levels in the interstitial fluid. The wire-type sensor is inserted subcutaneously and is coated with an enzyme that causes a reduction-oxidation reaction when interacting w

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosed with type 1 diabetes mellitusUsing the Inreda AP system for a minimum of 3 monthsMinimum age of 18 yearsWilling and able to sign informed consent

Exclusion criteria

Exclusion criteria: Unable to wear Inreda CGM glucose sensor on their armPregnancy and/or breastfeedingHbA1c > 97 mmol/molUse of oral antidiabetic agentsUse of acetaminophen (paracetamol)Use of ascorbic acid (vitamin C) supplementsPheochromocytomaInsulinomaSevere liver, heart, or renal failureAlcohol abuse

Design outcomes

Primary

Measure	Time frame
The main parameter to express the accuracy of the sensor is the MARD (mean absolute relative difference) value between the Inreda CGM measurements and the SMBGs as a reference.	—

Secondary

Measure	Time frame
Additional accurcay parameters/endpoints are:Overall percentage of measured glucose values that fall within ±0.83 mmol/L of a SMBG measurement at a glucose level of <5.55 mmol/L;Overall percentage of measured glucose values that fall within 15% of a SMBG measurement at a glucose level of >5.55 mmol/L;Overall percentage of measured glucose values that fall in zone A and B of the Clarke Error Grid.The MARD and other accuracy parameters of the Guardian 4 sensor measurements to compare the performance of both sensors;Additional study parameters are:Time lag between the raw voltage current of the Inreda CGM sensor and the Guardian 4 sensor measurements;Time lag between the raw voltage current of the Inreda CGM sensor and the SMBG measurements;Percentage of time that the sensors are available as input for the algorithm;Lifetime of the sensors;Adverse Events;Device Deficiencies.	—

Measure

Time frame

Additional accurcay parameters/endpoints are:Overall percentage of measured glucose values that fall within ±0.83 mmol/L of a SMBG measurement at a glucose level of <5.55 mmol/L;Overall percentage of measured glucose values that fall within 15% of a SMBG measurement at a glucose level of >5.55 mmol/L;Overall percentage of measured glucose values that fall in zone A and B of the Clarke Error Grid.The MARD and other accuracy parameters of the Guardian 4 sensor measurements to compare the performance of both sensors;Additional study parameters are:Time lag between the raw voltage current of the Inreda CGM sensor and the Guardian 4 sensor measurements;Time lag between the raw voltage current of the Inreda CGM sensor and the SMBG measurements;Percentage of time that the sensors are available as input for the algorithm;Lifetime of the sensors;Adverse Events;Device Deficiencies.

—

Countries

Netherlands

Contacts

Public ContactHJG Smits

Inreda Diabetic B.V.

info@inredadiabetic.nl+31 (0) 547 26 26 28

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026