Status:
UNKNOWN
Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
Lead Sponsor:
Samsung Medical Center
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
NA
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 devel...
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 pu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03794934
Start Date
February 26 2019
End Date
December 31 2020
Last Update
March 25 2019
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710