Diabetes Mellitus, Type 1
Conditions
Keywords
Glucose Monitoring System
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.
Interventions
DEVICEGlucose 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.
Sponsors
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Test-to-Reference Measurement Pairs With an Absolute Relative Difference (ARD) ≤15% | 36 hours | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Glucose Sensor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Europe | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 3 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: 36 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Glucose Sensor | Percentage of Test-to-Reference Measurement Pairs With an Absolute Relative Difference (ARD) ≤15% | Abbot | 73.2 Percentage of sensor values |
| Glucose Sensor | Percentage of Test-to-Reference Measurement Pairs With an Absolute Relative Difference (ARD) ≤15% | Dexcom | 56.1 Percentage of sensor values |
| Glucose Sensor | Percentage of Test-to-Reference Measurement Pairs With an Absolute Relative Difference (ARD) ≤15% | Medtronic | 52.0 Percentage of sensor values |