An interventional study of Glucose Sensor in Diabetes Mellitus, Type 1, sponsored by Medical University of Graz. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Basic science
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
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Exclusion Criteria:
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).
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".
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
| Milestone | Glucose Sensor |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
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.
| Percentage of sensor values | Glucose Sensor |
|---|---|
| Abbot | 73.2 |
| Dexcom | 56.1 |
| Medtronic | 52.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glucose Sensor | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Event | Glucose Sensor |
|---|---|
| Superficial excoriationSkin and subcutaneous tissue disorders | 1/12 |
| HeadacheNervous system disorders | 1/12 |
| VertigoEar and labyrinth disorders | 1/12 |
| Age, Categorical(Participants) | Glucose Sensor |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Glucose Sensor |
|---|---|
| Female | 5 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Glucose Sensor |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Glucose Sensor |
|---|---|
| Europe | 12 |
No study locations are listed for this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Medical University of Graz