Diabetes Mellitus
Conditions
Keywords
Non-invasive glucose monitoring, Raman spectroscopy
Brief summary
This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.
Interventions
DEVICEP0.3
Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.
Sponsors
Steno Diabetes Center Copenhagen
RSP Systems A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects between 18 and 40 years of age. * Diagnosed with type 1 diabetes mellitus. * Uses an insulin pen or pump. * Hb1Ac \> 55 mmol/mol at baseline visit. * Skin phototype 1-4 according to Fitzpatrick skin tone scale. * Willing to perform a minimum of 8 finger sticks per day during the study for the home-based study and approximately 16 finger sticks for the in-clinic study days. * Willing to have a peripheral venous catheter inserted. * Willing to provide written signed and dated informed consent.
Exclusion criteria
* Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control according to approved contraceptives from NCA during the study execution (applicable to female subjects only). * Subjects not able to understand and read Danish. * Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator. * Subject is not able to hold hand/arm steadily (including tremors and Parkinson's Disease). * Reduced circulation in hand. Allen's test is used for assessing hand circulation to evaluate occurrence of reduced blood. * Extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements. * Known allergy to medical grade alcohol. * Having active cancer treatment and/or use tetracyclines and other medication / topical agents known to increase photosensitivity in skin. * Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate * Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff. * Diagnosed with cardiovascular diseases. * Subjects currently enrolled in another study. * Radiotherapy for the past six months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generation of predictive algorithms for determining blood glucose levels | 12 months | Collected spectral raman data will found the development of predictive algorithms for glucose determination. |
| Validation of predictive algorithms for determining blood glucose levels | 12 months | Performance of predictive models will be evaluated using the consensus error grid.Unified Performance (ISUP), Mean Absolute Relative Difference (MARD) and Consensus Error Grid (CEG) distribution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk/benefit analysis | 12 months | Support of a favorable risk/benefit analysis based on reported Adverse Device Effects and Serious Adverse Device Effects. |
| Number of encountered Device Deficiencies | 12 months | Evaluation of Device Deficiencies with respect to identity, quality, durability or reliability, including malfunctions, use errors and inadequate labeling. |
Countries
Denmark
Outcome results
None listed