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

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.

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Structured Education for new glucose management devices

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Jae Hyeon Kim, M.D.,Ph. D; Phone Number: 82-2-3410-1580; Email: jaehyeonmd.kim@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; 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; Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
Active Comparator: Intervention; provide structured education when applying CGM for 3 months	Behavioral: Structured Education for new glucose management devices; Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus

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)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Type 1 Diabetes Mellitus; Insulin pump; Structured Education
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2018-12-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No