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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Structured Education for new glucose management devices
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, Continuous Glucose Monitoring, Insulin pump, Structured Education

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Intervention

Arm Description

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

provide structured education when applying CGM for 3 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of time in level 2 hypoglycemia (<54mg/dL)
Percentage of time in level 2 hypoglycemia (<54mg/dL) by continuous glucose monitoring system
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
Percentage of time in level 1 hyperglycemia (>180mg/dL)
Percentage of time in level 1 hyperglycemia (>180mg/dL) by continuous glucose monitoring system
Percentage of time in level 2 hyperglycemia (>250mg/dL)
Percentage of time in level 2 hyperglycemia (>250mg/dL) by continuous glucose monitoring system
Glycemic variability, reported as coefficient of variance (CV)
Glycemic variability, reported as coefficient of variance (CV) by continuous glucose monitoring system
Glycemic variability, reported as standard deviation (SD)
Glycemic variability, reported as standard deviation (SD) by continuous glucose monitoring system
Mean glucose by continuous glucose monitoring system
Mean glucose by continuous glucose monitoring system
HbA1C
HbA1C
glycated albumin
glycated albumin
Personalized education time for each patient
Personalized education time for each patient
Frequency of hypoglycemia
Frequency of hypoglycemia
Adverse event
Adverse event occurred
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

Full Information

First Posted
January 4, 2019
Last Updated
March 21, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03794934
Brief Title
Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
Acronym
Education
Official Title
Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus, Continuous Glucose Monitoring, Insulin pump, Structured Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
CGM apply followed by structured education of CGM
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
provide structured education when applying CGM for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Structured Education for new glucose management devices
Intervention Description
Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
Primary Outcome Measure Information:
Title
Percentage of time in target range 70-180 mg/dL
Description
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Secondary Outcome Measure Information:
Title
Percentage of time in level 2 hypoglycemia (<54mg/dL)
Description
Percentage of time in level 2 hypoglycemia (<54mg/dL) by continuous glucose monitoring system
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
Percentage of time in level 1 hypoglycemia (<70-54mg/dL)
Description
Percentage of time in level 1 hypoglycemia (<70-54mg/dL) by continuous glucose monitoring system
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
Percentage of time in level 1 hyperglycemia (>180mg/dL)
Description
Percentage of time in level 1 hyperglycemia (>180mg/dL) by continuous glucose monitoring system
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
Percentage of time in level 2 hyperglycemia (>250mg/dL)
Description
Percentage of time in level 2 hyperglycemia (>250mg/dL) by continuous glucose monitoring system
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
Glycemic variability, reported as coefficient of variance (CV)
Description
Glycemic variability, reported as coefficient of variance (CV) by continuous glucose monitoring system
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
Glycemic variability, reported as standard deviation (SD)
Description
Glycemic variability, reported as standard deviation (SD) by continuous glucose monitoring system
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
Mean glucose by continuous glucose monitoring system
Description
Mean glucose by continuous glucose monitoring system
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
HbA1C
Description
HbA1C
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
glycated albumin
Description
glycated albumin
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
Personalized education time for each patient
Description
Personalized education time for each patient
Time Frame
baseline (intervention group) and 3months (for extension study in control group)
Title
Frequency of hypoglycemia
Description
Frequency of hypoglycemia
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
Adverse event
Description
Adverse event occurred
Time Frame
3months (control and intervention groups) and 6months (for extension study in control group)
Title
Percentage of time in target range 70-180 mg/dL
Description
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
Time Frame
6months (for extension study in control group)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Hyeon Kim, MD PhD
Phone
82-2-3410-3439
Email
jaehyeonmd.kim@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Hyeon Kim, M.D.,Ph. D
Phone
82-2-3410-1580
Email
jaehyeonmd.kim@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35065101
Citation
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.
Results Reference
derived

Learn more about this trial

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

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