Clinical trial NCT04926623: Freestyle Libre-based Education on MDI in T2DM (FreEdoM-2)
Official title: Multicenter, Open-label, Randomized Trial to Compare the Effectiveness of Structured Education and Safety of FreeStyle Libre or Self-Monitoring of Blood Glucose (SMBG) in Patients With Type 2 Diabetes Mellitus Using Multiple Daily Injections or Insulin Pumps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 159
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Multicenter, Open-label, Randomized Trial to Compare the Effectiveness of Structured Education and Safety of FreeStyle Libre or Self-Monitoring of Blood Glucose (SMBG) in patients with type 2 Diabetes Mellitus using Multiple Daily Injections or Insulin Pumps

Detailed description: All subjects must participate in Blind Continuous Glucose Monitoring(CGM) for two weeks prior to Visit 2 visit (random assignment).

Subjects who meet the selection/exclusion criteria in Visit 2 visits are randomly assigned to the test group (personal in-depth education and FreeStyle Libre) or control 1 (standard education and FreeStyle Libre) or control 2 (standard education and SMBG) at a 1:1:1 ratio.

In the test group, personal in-depth education is conducted at baseline (Visit 2), 4 weeks (Visit 3), 8 weeks (Visit 4), 12 weeks (Visit 5), and 18 weeks (Visit 6), and the time required for education and preparation time required for patient education are checked.

Control groups 1 and 2 conduct routine insulin basic injection training as standard education at baseline (Visit 2) and 12 weeks (Visit 5).

After randomization, FreeStyle Libre is applied to the test group and control group 1 for 24 weeks, and SMBG is performed for 22 weeks and Blind CGM is applied for 2 weeks at 22 weeks (Visit 7).

Blood glucose measurements collected from FreeStyle Libre are collected through the reader program, and are checked in real time by researchers and used for education, research, and analysis. Prior to the implementation of FreeStyle Libre for the collection of real-time blood sugar collected through FreeStyle Libre, the subject is given consent to disclose blood sugar information.

All subjects visit baseline (Visit 2), 12 weeks (Visit 5), and 24 weeks (Visit 8) to conduct surveys on physical examinations, blood tests and urine tests (Central Lab), and treatment satisfaction questionnaire (DTSQ).

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes patients aged 19 and under 75 years.
2. Multiple insulin injections at the time of screening (at least one base insulin and two or more fast-acting insulin. However, one insulin aspart/insulin degludec + one insulin aspart or two or more insulin aspart/insulin degludec can be included.) or those who have been using an insulin pump for at least 12 weeks.
3. HbA1c of not less than 7.5% and not more than 12.0% at the time of screening
4. patients who agree to use FreeStyle Libre for medical care and research
5. patients who voluntarily signed a written consent form

Exclusion Criteria:

1. Those who have difficulty in education due to severe systemic diseases (e.g., terminal renal failure requiring dialysis, cirrhosis above Child-Pugh Class C), cognitive impairment, and mental illness.
2. Those who are taking drugs that may affect metabolism per screening time (e.g., adrenocortical hormones, immunosuppressants, etc.) (However, those who have taken the same dose for more than 12 weeks until screening time and who are not scheduled to change drug dose can participate in this study.)
3. Those with clinically significant cardiovascular diseases (heart failure, angina, myocardial infarction, cerebral infarction, etc.) within 24 weeks of screening.
4. Those who have a glomerular filtration rate (eGFR) of \<15 mL/min.
5. A person with severe diabetes complications that deteriorate or newly occur within 3 months of screening and require emergency treatment.
6. Pregnant or lactating persons.
7. Pregnancy is planned during the study period, effective contraception (if condoms, oral contraceptives, intrauterine contraceptives, injections, transplants, contraceptives, or absolute abstinence, such as periodic abstinence (e.g., Krenda, ovulation, symptom body temperature) and resection are not considered as recognized contraceptives) for women or men.
8. Those who find other researchers inappropriate for participation in research.

Primary outcomes:
measure: HbA1c (%) changes
timeFrame: 24 weeks
Secondary outcomes:
measure: HbA1c (%) changes
timeFrame: 12 weeks
measure: Percentage of time in level 2 hypoglycemia (<54 mg/dL)
timeFrame: 24 weeks
measure: Percentage of time in level 1 hypoglycemia (<70- 54 mg/dL)
timeFrame: 24 weeks
measure: Percentage of time in level 1 hypoglycemia (> 180 mg/dL)
timeFrame: 24 weeks
measure: Percentage of time in level 2 hypoglycemia (> 250 mg/dL)
timeFrame: 24 weeks
measure: Percentage of time in range (70 - 180mg/dL)
timeFrame: 24 weeks
measure: Mean glucose changes
timeFrame: 24 weeks
measure: Coefficient of variation(CV) changes
timeFrame: 24 weeks
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes
timeFrame: 12 weeks
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: