Sensor for Measuring the blood glucose level as input for the ARtificial pancreas: a sensor validation Trial.

Sensor for Measuring the blood glucose level as input for the ARtificial pancreas: a sensor validation Trial. - SMART 1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49011

Enrollment

Registered

2020-09-28

Start date

2020-11-11

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Diabetes type 1

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Diagnosed with diabetes mellitus type 1; * Age between 18 and 75 years; * Willing and able to sign informed consent.

Exclusion criteria

Exclusion criteria: * BMI > 35 kg/m2; * Skin condition prohibiting needle insertion; * Known or suspected problem related to enzyme based glucose sensor usage; * Use of acetaminophen during the study period; * Patients who go swimming or visit a sauna during the study period.

Design outcomes

Primary

Measure	Time frame
Main parameter to express glucose accuracy is the MARD value (mean absolute relative difference between self-monitoring of blood glucose (SMBG) measurements and Guardian Sensor 3 measurements).	—

Secondary

Measure	Time frame
Secondary accuracy parameters 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 in zone A and B of the Clarke Error Grid. * PARD value of the Guardian Sensor 3 in combination with the Enlite Sensor. AP-related outcome parameters are: * Life-time of the sensors; * Percentage of time that the sensors are available as input for the algorithm. Other study parameters are demographic characteristics, weight, length, HbA1c and amount of administered insulin during usual diabetes treatment.	—

Measure

Time frame

Secondary accuracy parameters 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 in zone A and B of the Clarke Error Grid. * PARD value of the Guardian Sensor 3 in combination with the Enlite Sensor. AP-related outcome parameters are: * Life-time of the sensors; * Percentage of time that the sensors are available as input for the algorithm. Other study parameters are demographic characteristics, weight, length, HbA1c and amount of administered insulin during usual diabetes treatment.

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Countries

Netherlands

Outcome results