Clarity (WIP)
Clarity Use case
The purpose of clarity app use case is defined below
Clarity: Collect Data : User (PwD) which has Clarity app installed and configured, Collects Data via Clarity App. After 3 Days, data will be sent to NexMed Module.
NextMed : Create report : NextMed system creates report available to PwD via Clarity App.
Clarity: View Report : PwD review the report on Clarity App. The report will be available for download in PDF format too.
NexMed: Treatment Recommendation : HCP can check Therapy History and Report created by the user in Portal. At this time, NexMed will use information gathered from Clarity and stored in FHIR to suggest practionoter a list of medications to prescribe.
NextMed : Prescribe Meds HCP (Doctor) Evaluated and prescribes medication via NextMed module
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 |
Profiles
List of profiles that are relevant to this application