Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Browse trials for

• Diabetes Mellitus, Type 2 9,339

Keywords

• type 2 diabetes
• continuous glucose monitoring

Study arms

• Experimental
  Periodic CGM Use

  All participants first wear FreeStyle Libre 2 CGM continuously for 12 weeks to establish baseline glucose patterns. Only those with at least 50% sensor active time proceed to randomization. After randomization, participants in this arm wear CGM intermittently for 2 weeks at weeks 2, 6, and 10 (±3 days each). Each sensor is worn for 14 days then removed. During non-wearing periods, no CGM is used. Participants receive education on diet adjustment based on postprandial glucose from CGM. Existing diabetes medications are maintained without changes throughout the study.

  Device: FreeStyle Libre 2 Continuous Glucose Monitoring

• Active comparator
  Continuous CGM Use

  All participants first wear FreeStyle Libre 2 CGM continuously for 12 weeks to establish baseline glucose patterns. Only those with at least 50% sensor active time proceed to randomization. After randomization, participants in this arm continue to wear CGM continuously for 12 weeks with sensor replacement every 14 days (total 6 replacements). Participants receive education on diet adjustment based on postprandial glucose from CGM. Existing diabetes medications are maintained without changes throughout the study.

  Device: FreeStyle Libre 2 Continuous Glucose Monitoring

Interventions

• DeviceFreeStyle Libre 2 Continuous Glucose Monitoring

  FreeStyle Libre 2 continuous glucose monitoring system consisting of a sensor worn on the upper arm that measures interstitial glucose levels continuously for up to 14 days. Data is transmitted to a smartphone app (FreeStyle LibreLink). The sensor is a Class 3 medical device approved by MFDS (Korea). Participants receive education on adjusting diet based on postprandial glucose patterns observed through CGM. Existing diabetes medications (oral agents and/or GLP-1 agonists) are maintained without changes throughout the intervention period.

Primary outcomes

1. Change in HbA1c from 3 to 6 months

   Non-inferiority comparison of the adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 (V2, randomization visit) to month 6 (V3, end of study). The non-inferiority margin is set at 0.3%. The periodic use group will be considered non-inferior to the continuous use group if the lower bound of the 97.5% one-sided confidence interval for the difference in HbA1c change (periodic minus continuous) is greater than -0.3%.

   Time frame: At 6 months (V3)

Secondary outcomes

1. Change in HbA1c

   Adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 to month 6, comparing periodic versus continuous CGM use groups.

   Time frame: At 6 months (V3)

2. Change in Blood Pressure

   Adjusted change in systolic and diastolic blood pressure from month 3 to month 6, comparing periodic versus continuous CGM use groups.

   Time frame: At 6 months (V3)

3. At 6 months (V3)

   Adjusted change in lipid parameters (LDL cholesterol, HDL cholesterol, total cholesterol, triglycerides) from month 3 to month 6, comparing periodic versus continuous CGM use groups.

   Time frame: At 6 months (V3)

4. Change in Body Weight

   Adjusted change in body weight (kg) from month 3 to month 6, comparing periodic versus continuous CGM use groups.

   Time frame: At 6 months (V3)

5. Change in HOMA-IR

   Adjusted change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from month 3 to month 6, comparing periodic versus continuous CGM use groups.

   Time frame: At 6 months (V3)

6. Change in Diabetes Treatment Satisfaction (DTSQ)

   Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score from month 3 to month 6, comparing periodic versus continuous CGM use groups. Higher scores indicate greater treatment satisfaction.

   Time frame: At 6 months (V3)

7. Change in Diabetes Self-Efficacy (K-DMSES)

   Change in Korean-Diabetes Management Self-Efficacy Scale (K-DMSES) score from month 3 to month 6, comparing periodic versus continuous CGM use groups. Higher scores indicate greater self-efficacy.

   Time frame: At 6 months (V3)

8. Change in Diabetes Self-Care Activities (SDSCA-K)

   Change in Summary of Diabetes Self-Care Activities Questionnaire-Korean (SDSCA-K) score from month 3 to month 6, comparing periodic versus continuous CGM use groups.

   Time frame: At 6 months (V3)

9. Time in Range 70-180 mg/dL (Non-inferiority)

   Non-inferiority comparison of percentage of time in glucose range 70-180 mg/dL between periodic and continuous CGM use groups. Non-inferiority margin is 6%.

   Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

10. Time in Range 70-180 mg/dL

    Percentage of time in glucose range 70-180 mg/dL, comparing periodic versus continuous CGM use groups.

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

11. Time in Tight Range 70-140 mg/dL

    Percentage of time in tight glucose range 70-140 mg/dL, comparing periodic versus continuous CGM use groups.

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

12. Time Above Range 180 mg/dL

    Percentage of time above glucose range (\>180 mg/dL), comparing periodic versus continuous CGM use groups.

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

13. Time Above Range 250 mg/dL

    Percentage of time above glucose range (\>250 mg/dL), comparing periodic versus continuous CGM use groups.

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

14. Time Below Range 70 mg/dL

    Percentage of time below glucose range (\<70 mg/dL), comparing periodic versus continuous CGM use groups.

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

15. Time Below Range 54 mg/dL

    Percentage of time below glucose range (\<54 mg/dL), comparing periodic versus continuous CGM use groups.

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

16. Glucose Standard Deviation (SD)

    Standard deviation of glucose levels, comparing periodic versus continuous CGM use groups.

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

17. Glucose Coefficient of Variation (CV)

    Coefficient of variation of glucose levels, comparing periodic versus continuous CGM use groups.

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

18. Mean Amplitude of Glycemic Excursions (MAGE)

    Mean amplitude of glycemic excursions, a measure of glucose variability, comparing periodic versus continuous CGM use groups.

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

19. Glucose Management Indicator (GMI)

    Glucose Management Indicator, an estimate of HbA1c derived from CGM data, comparing periodic versus continuous CGM use groups.

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

20. Mean Glucose

    Mean glucose level (mg/dL), comparing periodic versus continuous CGM use groups

    Time frame: Combined period of 3.5-4 months, 4.5-5 months, and 5.5-6 months

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in articles resulting from this study will be made available after deidentification. This includes data supporting primary and secondary outcomes, demographic information, and adverse event data. Data will be provided in a format suitable for secondary analysis while protecting participant privacy.

Supporting information: Study protocol, Sap, Icf, Csr