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

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ClinicalTrials.gov Identifier: NCT03794934
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Jae Hyeon Kim, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE January 4, 2019
First Posted Date  ICMJE January 7, 2019
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE February 26, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
Percentage of time in target range 70-180 mg/dL [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2019)
Percentage of time in target range 70-180 mg/dL [ Time Frame: 3months ]
Percentage of time in target range 70-180 mg/dL in continuous glucose monitoring system
Change History Complete list of historical versions of study NCT03794934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2019)
  • Percentage of time in level 2 hypoglycemia (<54mg/dL) [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Percentage of time in level 2 hypoglycemia (<54mg/dL) by continuous glucose monitoring system
  • Percentage of time in level 1 hypoglycemia (<70-54mg/dL) [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Percentage of time in level 1 hypoglycemia (<70-54mg/dL) by continuous glucose monitoring system
  • Percentage of time in level 1 hyperglycemia (>180mg/dL) [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Percentage of time in level 1 hyperglycemia (>180mg/dL) by continuous glucose monitoring system
  • Percentage of time in level 2 hyperglycemia (>250mg/dL) [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Percentage of time in level 2 hyperglycemia (>250mg/dL) by continuous glucose monitoring system
  • Glycemic variability, reported as coefficient of variance (CV) [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Glycemic variability, reported as coefficient of variance (CV) by continuous glucose monitoring system
  • Glycemic variability, reported as standard deviation (SD) [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Glycemic variability, reported as standard deviation (SD) by continuous glucose monitoring system
  • Mean glucose by continuous glucose monitoring system [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Mean glucose by continuous glucose monitoring system
  • HbA1C [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    HbA1C
  • glycated albumin [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    glycated albumin
  • Personalized education time for each patient [ Time Frame: baseline (intervention group) and 3months (for extension study in control group) ]
    Personalized education time for each patient
  • Frequency of hypoglycemia [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Frequency of hypoglycemia
  • Adverse event [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Adverse event occurred
  • Percentage of time in target range 70-180 mg/dL [ Time Frame: 6months (for extension study in control group) ]
    Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2019)
  • Percentage of time in level 2 hypoglycemia (<54mg/dL) [ Time Frame: 3 months ]
    Percentage of time in level 2 hypoglycemia (<54mg/dL) in continuous glucose monitoring system
  • Percentage of time in level 1 hypoglycemia (<70-54mg/dL) [ Time Frame: 3 months ]
    Percentage of time in level 1 hypoglycemia (<70-54mg/dL) in continuous glucose monitoring system
  • Percentage of time in level 1 hyperglycemia (>180mg/dL) [ Time Frame: 3 months ]
    Percentage of time in level 1 hyperglycemia (>180mg/dL) in continuous glucose monitoring system
  • Percentage of time in level 2 hyperglycemia (>250mg/dL) [ Time Frame: 3 months ]
    Percentage of time in level 2 hyperglycemia (>250mg/dL) in continuous glucose monitoring system
  • Glycemic variability, reported as CV [ Time Frame: 3 months ]
    Glycemic variability, reported as CV in continuous glucose monitoring system
  • Glycemic variability, reported as SD [ Time Frame: 3 months ]
    Glycemic variability, reported as SD in continuous glucose monitoring system
  • Mean glucose in CGM [ Time Frame: 3 months ]
    Mean glucose in CGM
  • HbA1C [ Time Frame: 3 months ]
    HbA1C
  • glycated albumin [ Time Frame: 3 months ]
    glycated albumin
  • Personalized education time for each patient [ Time Frame: Baseline or 3 months ]
    Personalized education time for each patient
  • Frequency of hypoglycemia [ Time Frame: 3 months or 6months ]
    Frequency of hypoglycemia
  • Adverse event [ Time Frame: 3 months or 6months ]
    Adverse event occurred
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
Official Title  ICMJE Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
CGM apply followed by structured education of CGM
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE Behavioral: Structured Education for new glucose management devices
Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Structured Education for new glucose management devices
  • Active Comparator: Intervention
    provide structured education when applying CGM for 3 months
    Intervention: Behavioral: Structured Education for new glucose management devices
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jae Hyeon Kim, MD PhD 82-2-3410-3439 jaehyeonmd.kim@samsung.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03794934
Other Study ID Numbers  ICMJE 2018-12-108
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jae Hyeon Kim, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP