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Patient benefits of a digital data platform for sickle cell disease

Digital sickle cell – evaluating live evidence for vaso-occlusive crisis and end-organ damage intervention & prevention: benefits of implementing a unified digital sickle cell disease data platform, including real-time wearable device data, in disease management, patient experience, and clinical outcomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN16126140
Enrollment
300
Registered
2020-09-09
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle cell disease Haematological Disorders Sickle-cell anaemia without crisis

Interventions

The study will be an observational trial, revolving around the use of a mobile app by participants in order to provide initial consent to participate and share their medical records with the study, ke

Sponsors

Eleven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children with sickle cell disease of any phenotype aged 5-15 years of age, with consent from and attendance/guidance by parent or legal guardian 2. Adults with sickle cell disease of any phenotype aged 16 years and over 3. Able and willing to sign written informed consent 4. Interest in participating in the study 5. Known history/diagnosis of sickle cell disease

Exclusion criteria

Exclusion criteria: 1. Incapacity to provide informed written consent 2. Known allergic reaction to any materials in wearable device

Design outcomes

Primary

MeasureTime frame
1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 3 months 2. Attrition rate recorded as the number of participants who consent to participate that remain in the study until the end of the follow-up period at 13 months

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

England, United Kingdom

Contacts

Public ContactKim Summers
kim@saniushealth.com+44 (0)7480149536

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026