Standardized procedure for the assessment of new-to-market continuous glucose monitoring systems

Standardized procedure for the assessment of new-to-market continuous glucose monitoring systems - SPACE2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36957

Enrollment

Registered

2012-12-17

Start date

2013-09-07

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

diabetes

Interventions

The study will use two marketed CGM systems (Dexcom G4 Platinum (Dexcom, USA) and the Medtronic Minimed Paradigm system (Medtronic, USA)). All two CGM sensors will be worn by the participant during

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * aged 18 years or above * diagnosed with Type 1 diabes mellitus at least 6 months according to the WHO definition * Body Mass Index (BMI)

Exclusion criteria

Exclusion criteria: Pregnancy use of medication which could influence glucometabolism use of paracetamol

Design outcomes

Primary

Measure	Time frame
Main study parameters will include blood glucose values and sensor glucose values. From the sensor glucose values the Mean and Median Absolute Relative Difference (MARD) compared to blood glucose values will be determined. Blood glucose values will consist of YSI values during the CRC period and fingerstick values thereafter. A separate analysis will be performed on the accuracy of the sensor in the hypoglycaemic (defined as a blood glucose value 3.9 mmol/L) and hyperglycaemic area (defined as a blood glucose value 10.0 mmol/L).	—

Measure

Time frame

Main study parameters will include blood glucose values and sensor glucose values. From the sensor glucose values the Mean and Median Absolute Relative Difference (MARD) compared to blood glucose values will be determined. Blood glucose values will consist of YSI values during the CRC period and fingerstick values thereafter. A separate analysis will be performed on the accuracy of the sensor in the hypoglycaemic (defined as a blood glucose value *3.9 mmol/L) and hyperglycaemic area (defined as a blood glucose value *10.0 mmol/L).

—

Secondary

Measure	Time frame
A separate analysis will be performed to assess sensor performance and accuracy per day of sensor life and during the entire sensor life.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)