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| Name | Class |
|---|---|
| Inje University | OTHER |
| Kangbuk Samsung Hospital | OTHER |
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We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose.
Specifically, this is a randomized, open-label, controlled study where half of the study participants will have FreeStyle Libre device on for 12 weeks and compare the change in glycated hemoglobin (HbA1c) value with the patients in the control group.
Subjects: 126 patients with type 2 diabetes mellitus Scheme: Multi-center, Randomized, open-label, controlled study
This study is referred to as the "Patient-Driven lifestyle modification using FreeStyle Libre in type 2 diabetes patients", also known as the PDF study.
It will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus Self Monitoring of Blood Glucose (SMBG) when combined with personalized education on lifestyle modification in people with type 2 diabetes. Specifically, we will investigate patients who have an elevated HbA1c between 7.0 - 10.0% who are not using prandial insulin.
Potential participants will be screened from routine outpatient clinic visits, will be randomized to either the CGM or SMBG group in a 1:1 ratio. Participants from both groups will receive education on lifestyle modification and will be reminded every 4 weeks with structured phone visits. Study will be completed at the visit on 12 weeks of follow up with the same laboratory examinations (including HbA1c) and survey from the baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FreeStyle Libre (CGM) Group | Experimental | Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification |
|
| Self Monitoring of Blood Glucose (SMBG) Group | Active Comparator | Device: Blood glucose meter Education on lifestyle modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre | Device | Flash glucose monitoring + Education on lifestyle modification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3 | Baseline to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean fasting glucose | Between group differences (CGM and SMBG) for the change in fasting glucose from baseline to Month 3 | Baseline to Month 3 |
| Change in body weight | Between group differences (CGM and SMBG) for the change in body weight from baseline to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CGM time in target range | Change in CGM time in target range 70-180 mg/dL from baseline to Month 3 in the CGM group | Baseline to Month 3 |
| Change in CGM time-hyperglycemic | Change in CGM time in time above target range, defined as >250 mg/dL from baseline to Month 3 in the CGM group |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hun Jee Choe, MD | Contact | 82-2-2072-1965 | hunjeechoe@snu.ac.kr | |
| Young Min Cho, MD, PhD | Contact | 82-2-2072-1965 | ymchomd@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Young Min Cho, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35984640 | Derived | Choe HJ, Rhee EJ, Won JC, Park KS, Lee WY, Cho YM. Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study. Diabetes Care. 2022 Oct 1;45(10):2224-2230. doi: 10.2337/dc22-0764. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 25, 2022 | Nov 18, 2022 | 1 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Blood glucose meter | Device | Self monitoring of blood glucose + Education on lifestyle modification |
|
|
| Baseline to Month 3 |
| Change in blood pressure | Between group differences (CGM and SMBG) for the change in blood pressure from baseline to Month 3 | Baseline to Month 3 |
| Change in waist circumference | Between group differences (CGM and SMBG) for the change in waist circumference from baseline to Month 3 | Baseline to Month 3 |
| Change in lipid level | Between group differences (CGM and SMBG) for the change in lipid level (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) from baseline to Month 3 | Baseline to Month 3 |
| Change in the Korean Version of Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K) survey score | Between group differences (CGM and SMBG) for the change in survey score from baseline to Month 3 | Baseline to Month 3 |
| Baseline to Month 3 |
| Change in CGM time-hypoglycemic | Change in CGM time in time below target range, defined as <70 mg/dL (level 1) and < 54 (level 2) from baseline to Month 3 in the CGM group | Baseline to Month 3 |
| Change in CGM glucose variability | Change in CGM glucose variability measured by the coefficient of variation from baseline to Month 3 in the CGM group | Baseline to Month 3 |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |