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NCT Number: NCT07336329

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

The goal of this clinical trial is to test whether wearing a continuous glucose monitor (CGM) part-time works as well as wearing it full-time in adults with type 2 diabetes who do not use insulin. The main questions it aims to answer are:

* Does wearing CGM part-time (2 weeks per month) control blood sugar as well as wearing it continuously? * How do the two wearing patterns compare for blood sugar levels throughout the day, weight, blood pressure, and patient satisfaction?

Researchers will compare part-time CGM use to continuous CGM use to see if part-time use is just as effective for blood sugar control.

All participants will:

* Wear a CGM device continuously for 3 months to learn how their blood sugar responds to different foods and activities * Then be randomly assigned to wear CGM either part-time (2 weeks each month) or continuously for another 3 months * Replace the CGM sensor on their arm every 2 weeks * Use a smartphone app to track their blood sugar readings * Visit the clinic 3 times for blood tests and check-ups * Receive education on adjusting diet based on their CGM readings * Keep their current diabetes medications unchanged during the study

The study will last about 6 months total. Participants will use the FreeStyle Libre 2 CGM device, which is already approved for use in people with diabetes.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 19 to 80 years at the time of informed consent
  • Adults with type 2 diabetes not using insulin
  • Patients treated with GLP-1 agonist, oral hypoglycemic agents, and/or lifestyle modifications
  • Patients who have maintained stable diabetes treatment for at least 3 months without changes
  • HbA1c between 7.5% and 10.0%
  • Willing to wear personal continuous glucose monitoring device (CGM)
  • Willing to install and use CGM-linked app on personal smartphone with continuous access to WIFI or cellular data
  • Able to read and write Korean as judged by investigator
  • Willing to use medically acceptable contraception until end of study (sterile status, intrauterine device, or concurrent use of male/female barrier method with spermicide)
  • Fully informed about the clinical trial and voluntarily consenting to participate

Exclusion criteria

  • Type 1 diabetes mellitus
  • Gestational diabetes mellitus
  • History of pancreatectomy
  • Continuous or intermittent insulin therapy for 7 days or more within 3 months
  • Oral or IV steroid treatment within 1 month prior to informed consent
  • Serious infection, surgery (scheduled or history), or severe trauma within 3 months prior to informed consent
  • History of malignancy within 1 year prior to informed consent (except thyroid cancer)
  • On hemodialysis or peritoneal dialysis or eGFR < 30 mL/min/1.73m2
  • Unable to avoid the following concomitant medications, devices, or treatments during the study: CGM other than study device, X-ray/MRI/CT scans, radiofrequency thermal therapy, implantable devices such as pacemakers, immunosuppressants, steroids, IV vitamin preparations, cancer treatment, hemodialysis/peritoneal dialysis, insulin therapy
  • Uncontrolled thyroid disease or clinically significant severe endocrine disorders (Cushing's syndrome, pheochromocytoma, etc.)
  • Severe allergic reaction to skin adhesives (e.g., dyspnea, severe rash, edema)
  • Whole blood donation within 60 days, apheresis within 30 days, or blood transfusion within 90 days prior to device application
  • Judged by investigator as unable to handle continuous glucose monitoring device
  • Pregnant or lactating women
  • Planning pregnancy within 1 year
  • Otherwise judged by investigator as inappropriate for participation in this clinical trial

Treatment and study plan

FreeStyle Libre 2 Continuous Glucose Monitoring

Device

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

    Time frame: At 6 months (V3)

    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%.

Secondary outcomes

  1. Change in HbA1c

    Time frame: At 6 months (V3)

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

  2. Change in Blood Pressure

    Time frame: At 6 months (V3)

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

  3. At 6 months (V3)

    Time frame: 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.

  4. Change in Body Weight

    Time frame: At 6 months (V3)

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

  5. Change in HOMA-IR

    Time frame: At 6 months (V3)

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

  6. Change in Diabetes Treatment Satisfaction (DTSQ)

    Time frame: At 6 months (V3)

    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.

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

    Time frame: At 6 months (V3)

    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.

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

    Time frame: At 6 months (V3)

    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.

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

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

    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%.

  10. Time in Range 70-180 mg/dL

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

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

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

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

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

  12. Time Above Range 180 mg/dL

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

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

  13. Time Above Range 250 mg/dL

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

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

  14. Time Below Range 70 mg/dL

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

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

  15. Time Below Range 54 mg/dL

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

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

  16. Glucose Standard Deviation (SD)

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

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

  17. Glucose Coefficient of Variation (CV)

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

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

  18. Mean Amplitude of Glycemic Excursions (MAGE)

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

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

  19. Glucose Management Indicator (GMI)

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

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

  20. Mean Glucose

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sun-Joon Moon, MD, PhD

CONTACT

[email protected]

+82-2-2001-1550

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

Effectiveness of Periodic Use of Continuous Glucose Monitoring After Three Months of Continuous Use in Patients With Non-Insulin-Treated Type 2 Diabetes Patients: A Multicenter, Randomized, Parallel-Group, Open-Label, Non-Inferiority, Investigator-Initiated Trial

Acronym: PERIODIC-CGM

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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