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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

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Structured Education for new glucose management devices Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: CGM apply followed by structured education of CGM
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. HbA1C [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    HbA1C

  9. glycated albumin [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    glycated albumin

  10. 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

  11. Frequency of hypoglycemia [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Frequency of hypoglycemia

  12. Adverse event [ Time Frame: 3months (control and intervention groups) and 6months (for extension study in control group) ]
    Adverse event occurred

  13. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794934


Contacts
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Contact: Jae Hyeon Kim, MD PhD 82-2-3410-3439 jaehyeonmd.kim@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Jae Hyeon Kim, M.D.,Ph. D    82-2-3410-1580    jaehyeonmd.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Jae Hyeon Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03794934     History of Changes
Other Study ID Numbers: 2018-12-108
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jae Hyeon Kim, Samsung Medical Center:
Type 1 Diabetes Mellitus
Continuous Glucose Monitoring
Insulin pump
Structured Education

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases