Clinical trial NCT03794934: Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus
Continuous Glucose Monitoring
Insulin pump
Structured Education
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CGM apply followed by structured education of CGM
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of time in target range 70-180 mg/dL
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
Secondary outcomes:
measure: Percentage of time in level 2 hypoglycemia (<54mg/dL)
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: Percentage of time in level 1 hypoglycemia (<70-54mg/dL)
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: Percentage of time in level 1 hyperglycemia (>180mg/dL)
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: Percentage of time in level 2 hyperglycemia (>250mg/dL)
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: Glycemic variability, reported as coefficient of variance (CV)
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: Glycemic variability, reported as standard deviation (SD)
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: Mean glucose by continuous glucose monitoring system
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: HbA1C
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: glycated albumin
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: Personalized education time for each patient
timeFrame: baseline (intervention group) and 3months (for extension study in control group)
measure: Frequency of hypoglycemia
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: Adverse event
timeFrame: 3months (control and intervention groups) and 6months (for extension study in control group)
measure: Percentage of time in target range 70-180 mg/dL
timeFrame: 6months (for extension study in control group)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
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.