Standardized Evaluation of Subcutaneous Glucose Monitoring Systems Under Routine Environmental Conditions

NCT ID: NCT02614768

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-09-30

Brief 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.

Detailed 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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Glucose Sensor

Continuous subcutaneous glucose monitoring using four different CGM systems in parallel will be performed throughout the study. Insulin therapy will be performed by the subjects themselves, as under daily life conditions. For the hypoglycaemia experiment an increased insulin bolus will be administered with meals (180% of the subject's calculated mealtime dose).

Group Type: EXPERIMENTAL

Glucose Sensor

Intervention Type: DEVICE

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".

Interventions

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".

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Mader, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Other Identifiers

SPIDIMAN_01

Identifier Type: -

Identifier Source: org_study_id