Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, continuous glucose monitoring
Brief summary
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.
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.
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a non-inferiority trial comparing periodic versus continuous use of CGM
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c from 3 to 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | 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. |
| At 6 months (V3) | 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. |
| Change in Body Weight | At 6 months (V3) | Adjusted change in body weight (kg) from month 3 to month 6, comparing periodic versus continuous CGM use groups. |
| Change in HOMA-IR | 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. |
| Change in Diabetes Treatment Satisfaction (DTSQ) | 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. |
| Change in Diabetes Self-Efficacy (K-DMSES) | 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. |
| Change in Diabetes Self-Care Activities (SDSCA-K) | 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. |
| Time in Range 70-180 mg/dL (Non-inferiority) | 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%. |
| Time in Range 70-180 mg/dL | 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. |
| Change in HbA1c | At 6 months (V3) | Adjusted change in glycated hemoglobin A1c (HbA1c) from month 3 to month 6, comparing periodic versus continuous CGM use groups. |
| Time Above Range 180 mg/dL | 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. |
| Time Above Range 250 mg/dL | 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. |
| Time Below Range 70 mg/dL | 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. |
| Time Below Range 54 mg/dL | 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. |
| Glucose Standard Deviation (SD) | 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. |
| Glucose Coefficient of Variation (CV) | 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. |
| Mean Amplitude of Glycemic Excursions (MAGE) | 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. |
| Glucose Management Indicator (GMI) | 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. |
| Mean Glucose | 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 |
| Time in Tight Range 70-140 mg/dL | 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. |
Countries
South Korea
Contacts
Primary ContactSun-Joon Moon, MD, PhD
Outcome results
None listed