Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus (Education)
Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Seoul、大韓民国、135-710
- 募集
- Samsung Medical Center
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コンタクト：
- Jae Hyeon Kim, M.D.,Ph. D
- 電話番号：82-2-3410-1580
- メール：jaehyeonmd.kim@samsung.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：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
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Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
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アクティブコンパレータ：Intervention
provide structured education when applying CGM for 3 months
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Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of time in target range 70-180 mg/dL
時間枠：3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of time in level 2 hypoglycemia (<54mg/dL)
時間枠：3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 2 hypoglycemia (<54mg/dL) by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
|
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Percentage of time in level 1 hypoglycemia (<70-54mg/dL)
時間枠：3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 1 hypoglycemia (<70-54mg/dL) by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 1 hyperglycemia (>180mg/dL)
時間枠：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
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3months (control and intervention groups) and 6months (for extension study in control group)
|
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Percentage of time in level 2 hyperglycemia (>250mg/dL)
時間枠：3months (control and intervention groups) and 6months (for extension study in control group)
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Percentage of time in level 2 hyperglycemia (>250mg/dL) by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
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Glycemic variability, reported as coefficient of variance (CV)
時間枠：3months (control and intervention groups) and 6months (for extension study in control group)
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Glycemic variability, reported as coefficient of variance (CV) by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
|
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Glycemic variability, reported as standard deviation (SD)
時間枠：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
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3months (control and intervention groups) and 6months (for extension study in control group)
|
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Mean glucose by continuous glucose monitoring system
時間枠：3months (control and intervention groups) and 6months (for extension study in control group)
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Mean glucose by continuous glucose monitoring system
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3months (control and intervention groups) and 6months (for extension study in control group)
|
|
HbA1C
時間枠：3months (control and intervention groups) and 6months (for extension study in control group)
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HbA1C
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3months (control and intervention groups) and 6months (for extension study in control group)
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glycated albumin
時間枠：3months (control and intervention groups) and 6months (for extension study in control group)
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glycated albumin
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3months (control and intervention groups) and 6months (for extension study in control group)
|
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Personalized education time for each patient
時間枠：baseline (intervention group) and 3months (for extension study in control group)
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Personalized education time for each patient
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baseline (intervention group) and 3months (for extension study in control group)
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Frequency of hypoglycemia
時間枠：3months (control and intervention groups) and 6months (for extension study in control group)
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Frequency of hypoglycemia
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3months (control and intervention groups) and 6months (for extension study in control group)
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Adverse event
時間枠：3months (control and intervention groups) and 6months (for extension study in control group)
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Adverse event occurred
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3months (control and intervention groups) and 6months (for extension study in control group)
|
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Percentage of time in target range 70-180 mg/dL
時間枠：6months (for extension study in control group)
|
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
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6months (for extension study in control group)
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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