Diabetes Mellitus, Type 2, Lifestyle Risk Reduction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFreeStyle Libre
Flash glucose monitoring + Education on lifestyle modification
DEVICEBlood glucose meter
Self monitoring of blood glucose + Education on lifestyle modification
Sponsors
Inje University
Kangbuk Samsung Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 19-80 * Diagnosed with type 2 diabetes mellitus (DM) * Uncontrolled type 2 DM: HbA1c 7.0-10.0% * Signed informed consent
Exclusion criteria
* Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM) * Use of prandial insulin * Change in diabetes medication in the preceding 3 months * Pregnant/lactating women * Addiction to drugs and alcohol * Use of medications that result in drug-induced hyperglycemia (i.e. steroid) * Severe liver disease * End-stage renal disease (i.e. on dialysis) * Unable to wear CGM devices due to dermatologic side effects (i.e. severe burn, inflammation, active skin infection, severe skin reactions, hypertrichosis, etc.) * Conditions that impact the stability of HbA1c measurement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Baseline to Month 3 | Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Baseline to Month 3 | Between group differences (CGM and SMBG) for the change in body weight from baseline to Month 3 |
| Change in blood pressure | Baseline to Month 3 | Between group differences (CGM and SMBG) for the change in blood pressure from baseline to Month 3 |
| Change in waist circumference | Baseline to Month 3 | Between group differences (CGM and SMBG) for the change in waist circumference from baseline to Month 3 |
| Change in lipid level | Baseline to Month 3 | 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 |
| Change in the Korean Version of Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K) survey score | Baseline to Month 3 | Between group differences (CGM and SMBG) for the change in survey score from baseline to Month 3 |
| Change in mean fasting glucose | Baseline to Month 3 | Between group differences (CGM and SMBG) for the change in fasting glucose from baseline to Month 3 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in CGM time-hypoglycemic | Baseline to Month 3 | 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 |
| Change in CGM glucose variability | Baseline to Month 3 | Change in CGM glucose variability measured by the coefficient of variation from baseline to Month 3 in the CGM group |
| Change in CGM time-hyperglycemic | Baseline to Month 3 | Change in CGM time in time above target range, defined as \>250 mg/dL from baseline to Month 3 in the CGM group |
| Change in CGM time in target range | Baseline to Month 3 | Change in CGM time in target range 70-180 mg/dL from baseline to Month 3 in the CGM group |
Countries
South Korea
Contacts
Primary ContactHun Jee Choe, MD
Backup ContactYoung Min Cho, MD, PhD
Outcome results
None listed