HerDiabetes for Academic Research
A Privacy-First, On-Device Utility for Cycle-Aware Diabetes Research
For university researchers and clinical trial sponsors, HerDiabetes serves as a zero-liability, on-device data collection utility.
It allows research participants to format and export high-density, real-world data (RWD) directly to study teams without exposing institutions to vendor cloud vulnerabilities, HIPAA business associate agreements (BAAs), or complex vendor IRB dependencies.
Export Dataset Features
Glucose Metrics: High-density interstitial glucose logs extracted directly from Apple Health.
Gynecological Tags: Menstrual cycle phase, cycle day (Day 1–35+), and ovulation estimations.
Participant Anonymization: Optional entry field for study-assigned Subject IDs
Contextual Markers: Surveys, symptom tags, carbohydrate estimates, Logged exercise intensity, and more.
Institutional & Regulatory Advantages
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Under OHRP guidance, the HerDiabetes vendor is legally "Not Engaged" in human subjects research. Because the software operates strictly on-device without remote servers or vendor data access:
The university Principal Investigator (PI) maintains 100% governance over participant consent and data custody.
No separate vendor IRB approval or software audit clearance is required.
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Under Section 3060 of the 21st Century Cures Act (FD&C Act § 520(o)(1)(D)), local file generation and data formatting utilities are classified as Non-Device Medical Device Data Systems (Non-Device MDDS). HerDiabetes functions passively to export HealthKit data without automated treatment decisions.
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The export engine programmatically strips hardware serial numbers and OS identifiers (IDFV/IDFA, in strict compliance with 45 CFR § 164.514(b). Data provenance is preserved via standardized ISO-8601 UTC timestamps and structured cycle phase metadata.
Partner with HerDiabetes for Your Study
Whether you're building a protocol or actively recruiting, share your study details below to explore on-device data collection.