Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614768
• Other study ID #: SPIDIMAN_01
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: May 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess accuracy and reliability of the SPIDIMAN continuous glucose monitoring (CGM) sensor system with regard to values as measured by Super GL and compare these results with similar evaluations of the Medtronic MiniMed 640G system, the Abbott FreeStyle Libre Flash Sensor and the DexCom G4 Platinum Sensor in patients with type 1 Diabetes.

Description:

The study is a single-center open-label study in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) therapy. The study will include a total of 12 subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent obtained after being advised of the nature of the study

• Male or female aged =18 years

• Type 1 diabetes for at least 6 months according to the World Health Organization (WHO) definition

• Treatment with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months

• Body Mass Index (BMI) < 35 kg/m²

• Willing and able to wear 5 CGM devices for the duration of the study and undergo all study procedures.

• HbA1c = 86 mmol/mol

Exclusion Criteria:

• Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

• Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods

• Any mental condition rendering the subject incapable of giving his consent

• Subject is using a medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration

• Subject may not use acetaminophen (paracetamol) while participating in the study

• Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study.

• Subject is actively enrolled in another clinical trial

• Known adrenal gland problem, pancreatic tumour, or insulinoma

• Inability of the subject to comply with all study procedures

• Inability of the subject to understand the patient information.

• Subject donated blood in the last 3 months

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Glucose Sensor
The investigational intervention is CGM monitoring using four different CGM systems. Three of the four CGM devices which are used will be CGM systems which have received conformité européenne (CE) certification (Dexcom G4 Platinum, Medtronic MiniMed 640G system, Abbott FreeStyle Libre Flash). The SPIDIMAN sensor will be used for the first time in human subjects, does not yet have received CE certification and will be given an identifying label in addition to being labelled "for investigative use only".

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Test-to-Reference Measurement Pairs With an Absolute Relative Difference (ARD) =15%	The primary outcome measure was overall sensor accuracy determined using ISO 15197:2013, which is percentage (%) of sensor values that are within ±0.8 mmol/L of the reference value at glucose concentrations <5.6 mmol/L and within ±15% at glucose concentrations =5.6 mmol/L. The sensor values were obtained using three different glucose monitoring systems, i.e. Abbott, Dexcom and Medtronic, in patients with T1D over a 12-hour period in standardized conditions. The reference values were obtained by analysis of venous plasma glucose samples.	36 hours