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

Type 1 Diabetes Mellitus Clinical Trial

— Education  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03794934
• Other study ID #: 2018-12-108
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2019
• Source: Samsung Medical Center
• Contact: Jae Hyeon Kim, MD PhD
• Phone: 82-2-3410-3439
• Email: jaehyeonmd.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Structured Education for new glucose management devices
Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	HbA1C	HbA1C	3months (control and intervention groups) and 6months (for extension study in control group)
Secondary	glycated albumin	glycated albumin	3months (control and intervention groups) and 6months (for extension study in control group)
Secondary	Personalized education time for each patient	Personalized education time for each patient	baseline (intervention group) and 3months (for extension study in control group)
Secondary	Frequency of hypoglycemia	Frequency of hypoglycemia	3months (control and intervention groups) and 6months (for extension study in control group)
Secondary	Adverse event	Adverse event occurred	3months (control and intervention groups) and 6months (for extension study in control group)
Secondary	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)