Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients

Diabetes Mellitus, Type 2 Clinical Trial

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Official title:

Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932928
• Other study ID #: H-2011-062-117
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: March 23, 2023

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: Hun Jee Choe, MD
• Phone: 82-2-2072-1965
• Email: hunjeechoe[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: March 23, 2023
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Lifestyle Risk Reduction

Intervention

Device:
• FreeStyle Libre
Flash glucose monitoring + Education on lifestyle modification
• Blood glucose meter
Self monitoring of blood glucose + Education on lifestyle modification

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Inje University, Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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	Baseline to Month 3
Other	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
Other	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
Primary	Change in HbA1c	Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3	Baseline to Month 3
Secondary	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
Secondary	Change in body weight	Between group differences (CGM and SMBG) for the change in body weight from baseline to Month 3	Baseline to Month 3
Secondary	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
Secondary	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
Secondary	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
Secondary	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