Clarity - Medication :

Medication intake/administration is one of the four data groups that patients, enrolled to the clarity/Nexmed programme, will have to log during the programme. The medications relevant for generation of the report are related to the patient's diabetes conditions, who are currently not under an insulin treatment. The information regarding medication are necessary for the calculation of the insulin need likelihood report datapoints.

Based on medical affairs's feedback - allowing PwD to select autonomously their medication might create a risk due to the selection of the wrong information. Instead, it should be the HCP to pre-define the list of medications that the PwD will select from to log their medication.

Due to fact NexMed integration is planned for 2022, in the feasibility study it will be implemented a different set up from the final commercial solution. In this solution, described in the next paragraph, the HCP will insert the medications during the PwD onboarding/set up.

Feasibility Study:

The key goal of the Feasibility (or Compliance) Study is to evaluate the compliance of PwDs in using the Clarity app for a number of consecutive days. The objective is to validate the assumption that Patients will be willing and actually use the app, reporting the needed Blood Glucose values, Meal information, Medication and Exercise levels in accordance with a test plan. After the study's conclusion patients will complete a questionnaire in order to identify potential gaps around compliance and to apply learnings to future iterations of the product.

Data Points

Data Point	Description	FHIR Resource & Element	Remarks (Unit/Data type)	FHIR Sample
Medications ->medication_id	Unique identifier of the medication	MedicationAdministration.medicationReference	String	Sample
Medications ->timestamp	Date of measurement	MedicationAdministration.effective[x]	datetime	Sample
Medications ->quantity	Amount of the consumed drug/medicine	MedicationAdministration.dosage.dose.value	int	Sample
Medications ->unit	unit of measurement	MedicationAdministration.dosage.dose.unit	Pill, IU	Sample
Medications ->active ingredient	active ingredient of the consumed drug/medicine	Substance.code.coding.code	string	Sample
Medications ->concentration	unit of measurement	Substance.ingredient.quantity	decimal	Sample