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).
Recommended Actions
- Develop comprehensive safety monitoring plan including stopping rules
- Establish clear inclusion/exclusion criteria based on HbA1c levels and treatment history
- Design study protocol with minimum 12-month follow-up for high-risk devices
- Implement standardized adverse event collection and documentation system
- Set up independent clinical events committee for adverse event adjudication
- Define rescue medication protocol for inadequate glycemic control
- Use NGSP-certified assay for HbA1c measurements
- Include control group whenever possible
- Document all patient demographics and comorbidities
- 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
- Sample size should consider device development phase and risk profile
- Control group recommended whenever possible
- Inclusion criteria should consider HbA1c levels (>7-8% but <10%)
- Subjects should have failed other treatments before enrollment
- Comorbidities should be controlled and stable
- Demographics (age, race, ethnicity, sex, gender, BMI) should be reported
- Standard lifestyle modification program should be maintained
Relevant Guidances
- Clinical Study Design for Surgical Ablation Devices Used in Treatment of Atrial Fibrillation Under Direct Visualization
- Design Considerations for Medical Device Pivotal Clinical Studies
- Sex-Specific Considerations in Medical Device Clinical Studies: Patient Enrollment, Data Analysis and Reporting
- Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
Related references and norms
- 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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