Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus

Study Overview
=================
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.

Detailed Description
-----------------
In 50 patients with type 1 diabetes with over 7% of glycated hemoglobin, whose blood glucose level is not well controlled, and who are undergoing multiple daily insulin injection therapy or insulin pump therapy, continuous glucose monitoring (CGM) is applied to obtain basal continuous glucose levels for 1 week (window period of 2 week). These 50 patients are 1:1 randomly assigned to 2 groups including control group and intervention group. Control group (n=25) applied CGM without structured education and after 3 months of applying CGM, continuous glucose data for 2 consecutive weeks and HbA1c level, and other glycometabolic parameters are collected. As a sequential extension clinical trial, those 25 patients in control group are provided structured education, followed by applying CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level, and other glycometabolic parameters are collected. In Intervention group (n=25), structured education program is provided for each patient from the time of enrollment, followed by applying CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level and other blood tests are performed after the 3 months.

Official Title
-----------------
Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Structured Education for new glucose management devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: CGM apply followed by structured education of CGM
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Without 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 | Behavioral: Structured Education for new glucose management devices<br>* Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus<br>|
| Active Comparator: Intervention<br>provide structured education when applying CGM for 3 months | Behavioral: Structured Education for new glucose management devices<br>* Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in level 2 hypoglycemia (<54mg/dL) | Percentage of time in level 2 hypoglycemia (<54mg/dL) by continuous glucose monitoring system | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| Percentage of time in level 1 hypoglycemia (<70-54mg/dL) | Percentage of time in level 1 hypoglycemia (<70-54mg/dL) by continuous glucose monitoring system | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| Percentage of time in level 1 hyperglycemia (>180mg/dL) | Percentage of time in level 1 hyperglycemia (>180mg/dL) by continuous glucose monitoring system | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| Percentage of time in level 2 hyperglycemia (>250mg/dL) | Percentage of time in level 2 hyperglycemia (>250mg/dL) by continuous glucose monitoring system | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| Glycemic variability, reported as coefficient of variance (CV) | Glycemic variability, reported as coefficient of variance (CV) by continuous glucose monitoring system | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| Glycemic variability, reported as standard deviation (SD) | Glycemic variability, reported as standard deviation (SD) by continuous glucose monitoring system | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| Mean glucose by continuous glucose monitoring system | Mean glucose by continuous glucose monitoring system | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| HbA1C | HbA1C | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| glycated albumin | glycated albumin | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| Personalized education time for each patient | Personalized education time for each patient | baseline (intervention group) and 3months (for extension study in control group) | 
| Frequency of hypoglycemia | Frequency of hypoglycemia | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| Adverse event | Adverse event occurred | 3months (control and intervention groups) and 6months (for extension study in control group) | 
| 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 | 6months (for extension study in control group) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes Mellitus, Continuous Glucose Monitoring, Insulin pump, Structured Education