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Clinical Studies for Medical Devices Treating Type 2 Diabetes Through Novel Therapeutic Approaches

This guidance focuses on feasibility and early feasibility clinical studies for medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus (T2DM). It covers devices like neurostimulators and those that mimic or result in anatomical changes similar to bariatric procedures. The guidance excludes devices for blood sugar monitoring, insulin/glucagon delivery, islet cell therapeutics, and Software as Medical Device (SaMD).

  1. Develop comprehensive safety monitoring plan including stopping rules
  2. Establish clear inclusion/exclusion criteria based on HbA1c levels and treatment history
  3. Design study protocol with minimum 12-month follow-up for high-risk devices
  4. Implement standardized adverse event collection and documentation system
  5. Set up independent clinical events committee for adverse event adjudication
  6. Define rescue medication protocol for inadequate glycemic control
  7. Use NGSP-certified assay for HbA1c measurements
  8. Include control group whenever possible
  9. Document all patient demographics and comorbidities
  10. Establish regular evaluation schedule with qualified healthcare professionals

Key Considerations

Clinical testing

  • Primary endpoints should address safety (adverse events) and effectiveness (HbA1c)
  • Follow-up period of at least 12 months for high-risk devices
  • Regular intervals for adverse event collection
  • Evaluation by diabetologist/endocrinologist at baseline and follow-up
  • Subject follow-up until resolution/stabilization of device-related adverse events

Human Factors

  • Subjects must be able to perform blood glucose monitoring
  • Subjects must be able to record medications and symptoms
  • Subjects must be able to communicate adverse events to investigators

Safety

  • Safety monitoring plan required for hypoglycemia/hyperglycemia management
  • Study stopping rules based on adverse events
  • Individual patient stopping rules
  • Medication management plan for inadequate glycemic control
  • Collection and documentation of all adverse events
  • Independent clinical events committee for adverse event adjudication

Other considerations

  • NGSP: National Glycohemoglobin Standardization Program

Original guidance

  • Clinical Studies for Medical Devices Treating Type 2 Diabetes Through Novel Therapeutic Approaches
  • HTML / PDF
  • Issue date: 2022-05-06
  • Last changed date: 2022-05-05
  • Status: FINAL
  • Official FDA topics: Medical Devices, Gastroenterology-Urology, Investigational Device Exemption (IDE), Premarket
  • ReguVirta summary file ID: df66a07d4fe9f0a9bf92668ca8d1ea1c
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