Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
Education
Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
1 other identifier
interventional
50
1 country
1
Brief Summary
Continuous glucose monitoring (CGM) and insulin pump, a new medical device, have been proved and highly recommended in the treatment of type 1 diabetes patients worldwide, and related technology development and market are growing rapidly. In order to maximize the medical and socioeconomic effects of the latest blood glucose devices including CGM and insulin pump, structured education is necessary. In this study, we will develop patient-oriented structured education for patients with type 1 diabetes mellitus when applying CGM, and we will assess the efficacy of this education protocol for patients with type 1 diabetes using CGM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Typical duration for not_applicable
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
January 4, 2019
CompletedFirst Posted
Study publicly available on registry
January 7, 2019
CompletedStudy Start
First participant enrolled
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 25, 2019
March 1, 2019
10 months
January 4, 2019
March 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of time in target range 70-180 mg/dL
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
3months (control and intervention groups) and 6months (for extension study in control group)
Secondary Outcomes (13)
Percentage of time in level 2 hypoglycemia (<54mg/dL)
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hypoglycemia (<70-54mg/dL)
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hyperglycemia (>180mg/dL)
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 2 hyperglycemia (>250mg/dL)
3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as coefficient of variance (CV)
3months (control and intervention groups) and 6months (for extension study in control group)
- +8 more secondary outcomes
Study Arms (2)
Control
PLACEBO COMPARATORWithout structured education when applying CGM for 3months, and as a sequential extension clinical trial, after 3 months, structured education is provided, followed by CGM apply
Intervention
ACTIVE COMPARATORprovide structured education when applying CGM for 3 months
Interventions
Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
Eligibility Criteria
You may qualify if:
- Over 18 years old - under 70 years old patients with Type 1 diabetes
- Those who plan to use CGM G5
- Patients who consented to use CGM G5 in conjunction with Clarity
- Those who are using multiple insulin injections or insulin pumps for at least 3 months
- Those whose fasting c-peptide \<0.6 ng / dL, or stimulated c-peptide \<1.8 ng / dL
- Those with a glycated hemoglobin of 7.0% or more within the last 3 months
- Those who have never used a CGM for more than a month
- For women of childbearing age, those who agree to use appropriate contraception during the trial
- Those who voluntarily signed the agreement after the explanation of the clinical trial
You may not qualify if:
- Those with a history of severe hypoglycemia and acute ketoacidosis within the last 3 months
- Patients with chronic renal function greater than or equal to stage 4 (estimated glomerular filtration rate \[assessed by MDRD (modification of diet in renal disease\] \<30 )
- Patients with acute myocardial infarction, unstable angina, coronary artery disease or stroke within the last 3 months
- Patients with adrenal insufficiency, pituitary dysfunction, medically uncontrolled hyperthyroidism or hypothyroidism
- Those taking medications that can affect the glucose metabolism (eg, corticosteroids, immunostimulants, etc.)
- Pregnant and lactating women
- A person who is deemed unsuitable for participation in clinical trials by examiners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (1)
Yoo JH, Kim G, Lee HJ, Sim KH, Jin SM, Kim JH. Effect of structured individualized education on continuous glucose monitoring use in poorly controlled patients with type 1 diabetes: A randomized controlled trial. Diabetes Res Clin Pract. 2022 Feb;184:109209. doi: 10.1016/j.diabres.2022.109209. Epub 2022 Jan 19.
PMID: 35065101DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 4, 2019
First Posted
January 7, 2019
Study Start
February 26, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2020
Last Updated
March 25, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share