Continuous Glucose Monitoring (CGM): Clinical Protocol and Implementation Guide

1. Patient Selection Criteria

Primary Indications

• Type 1 diabetes mellitus
• Insulin-dependent Type 2 diabetes with multiple daily injections
• History of severe hypoglycemia
• Hypoglycemia unawareness
• Pregnancy with diabetes

Contraindications

• Unwillingness to perform calibrations (if required)
• Inability to manage device technology
• Severe skin conditions at sensor sites

2. Pre-Implementation Assessment

Required Documentation

• HbA1c within past 3 months
• SMBG records review
• Insurance verification
• Signed informed consent

Equipment Selection

1. Real-time CGM systems
2. Intermittently scanned CGM
3. Professional CGM

3. Implementation Protocol

Initial Setup

1. Device programming
2. Sensor insertion
3. Transmitter attachment
4. Connection verification

Patient Education

• Sensor insertion/removal technique
• Calibration procedures (if applicable)
• Alert/alarm settings
• Troubleshooting common issues
• Data interpretation basics

4. Monitoring Parameters

Standard Targets

• Time in Range (TIR): 70-180 mg/dL (>70% of readings)
• Time Below Range: <70 mg/dL (<4% of readings)
• Time Above Range: >180 mg/dL (<25% of readings)

Alert Settings

• Low alert: 70-80 mg/dL
• High alert: 180-250 mg/dL
• Rate of change: ±2-3 mg/dL/min

5. Follow-up Protocol

Schedule

• 48-72 hours: Remote check
• 2 weeks: First follow-up
• 1 month: Comprehensive review
• 3 months: Regular follow-up

Assessment Points

• Data download and analysis
• Pattern identification
• Treatment adjustments
• Technical issues
• Patient compliance

6. Documentation Requirements

Each Visit

• Time in range metrics
• Sensor wear time
• Pattern analysis
• Intervention changes
• Patient education provided

7. Troubleshooting Guide

Common Issues

1. Sensor errors
2. Signal loss
3. Skin reactions
4. Calibration errors
5. Data gaps

Resolution Steps

• Follow manufacturer guidelines
• Document all technical issues
• Contact supplier support when needed

8. Quality Metrics

Success Indicators

• 70% sensor wear time

• 70% Time in Range

• Improved HbA1c
• Reduced hypoglycemic events
• Patient satisfaction scores