Freestyle Libre-based Education on MDI in T2DM (FreEdoM-2)
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
1 other identifier
interventional
159
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2021
CompletedFirst Posted
Study publicly available on registry
June 15, 2021
CompletedStudy Start
First participant enrolled
June 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2023
CompletedJune 14, 2024
June 1, 2024
1.4 years
June 10, 2021
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c (%) changes
HbA1c (%) changes at 24 weeks compared to baseline
24 weeks
Secondary Outcomes (10)
HbA1c (%) changes
12 weeks
Percentage of time in level 2 hypoglycemia (<54 mg/dL)
24 weeks
Percentage of time in level 1 hypoglycemia (<70- 54 mg/dL)
24 weeks
Percentage of time in level 1 hypoglycemia (> 180 mg/dL)
24 weeks
Percentage of time in level 2 hypoglycemia (> 250 mg/dL)
24 weeks
- +5 more secondary outcomes
Study Arms (3)
CGM with Structured Education
EXPERIMENTALCGM with Structured Education
CGM with Standard Education
ACTIVE COMPARATORCGM with Standard Education
SMBG with Standard Education
ACTIVE COMPARATORSMBG and CGM with Standard Education
Interventions
FreeStyle Libre flash sensor-based glucose monitoring system (FSGM; Abbott Diabetes Care, Witney, Oxon, UK)
Self-Monitoring of Blood Glucose and Continuous Glucose Monitoring
Eligibility Criteria
You may qualify if:
- Type 2 diabetes patients aged 19 and under 75 years.
- 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.
- HbA1c of not less than 7.5% and not more than 12.0% at the time of screening
- patients who agree to use FreeStyle Libre for medical care and research
- patients who voluntarily signed a written consent form
You may not qualify if:
- 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.
- 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.)
- Those with clinically significant cardiovascular diseases (heart failure, angina, myocardial infarction, cerebral infarction, etc.) within 24 weeks of screening.
- Those who have a glomerular filtration rate (eGFR) of \<15 mL/min.
- A person with severe diabetes complications that deteriorate or newly occur within 3 months of screening and require emergency treatment.
- Pregnant or lactating persons.
- 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.
- Those who find other researchers inappropriate for participation in research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (1)
Kim JY, Jin SM, Sim KH, Kim BY, Cho JH, Moon JS, Lim S, Kang ES, Park CY, Kim SG, Kim JH. Continuous glucose monitoring with structured education in adults with type 2 diabetes managed by multiple daily insulin injections: a multicentre randomised controlled trial. Diabetologia. 2024 Jul;67(7):1223-1234. doi: 10.1007/s00125-024-06152-1. Epub 2024 Apr 19.
PMID: 38639876DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2021
First Posted
June 15, 2021
Study Start
June 17, 2021
Primary Completion
October 26, 2022
Study Completion
April 4, 2023
Last Updated
June 14, 2024
Record last verified: 2024-06