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

2019년 3월 21일 업데이트: Jae Hyeon Kim, Samsung Medical Center

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.

연구 개요

상태

알려지지 않은

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 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
행동: Structured Education for new glucose management devices
Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
활성 비교기: Intervention
provide structured education when applying CGM for 3 months
행동: Structured Education for new glucose management devices
Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of time in target range 70-180 mg/dL
기간: 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
3months (control and intervention groups) and 6months (for extension study in control group)

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of time in level 2 hypoglycemia (<54mg/dL)
기간: 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
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hypoglycemia (<70-54mg/dL)
기간: 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
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 1 hyperglycemia (>180mg/dL)
기간: 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
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in level 2 hyperglycemia (>250mg/dL)
기간: 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
3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as coefficient of variance (CV)
기간: 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
3months (control and intervention groups) and 6months (for extension study in control group)
Glycemic variability, reported as standard deviation (SD)
기간: 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
3months (control and intervention groups) and 6months (for extension study in control group)
Mean glucose by continuous glucose monitoring system
기간: 3months (control and intervention groups) and 6months (for extension study in control group)
Mean glucose by continuous glucose monitoring system
3months (control and intervention groups) and 6months (for extension study in control group)
HbA1C
기간: 3months (control and intervention groups) and 6months (for extension study in control group)
HbA1C
3months (control and intervention groups) and 6months (for extension study in control group)
glycated albumin
기간: 3months (control and intervention groups) and 6months (for extension study in control group)
glycated albumin
3months (control and intervention groups) and 6months (for extension study in control group)
Personalized education time for each patient
기간: baseline (intervention group) and 3months (for extension study in control group)
Personalized education time for each patient
baseline (intervention group) and 3months (for extension study in control group)
Frequency of hypoglycemia
기간: 3months (control and intervention groups) and 6months (for extension study in control group)
Frequency of hypoglycemia
3months (control and intervention groups) and 6months (for extension study in control group)
Adverse event
기간: 3months (control and intervention groups) and 6months (for extension study in control group)
Adverse event occurred
3months (control and intervention groups) and 6months (for extension study in control group)
Percentage of time in target range 70-180 mg/dL
기간: 6months (for extension study in control group)
Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
6months (for extension study in control group)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Samsung Medical Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 2월 26일

기본 완료 (예상)

2019년 12월 31일

연구 완료 (예상)

2020년 12월 31일

연구 등록 날짜

최초 제출

2019년 1월 4일

QC 기준을 충족하는 최초 제출

2019년 1월 4일

처음 게시됨 (실제)

2019년 1월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 3월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 3월 21일

마지막으로 확인됨

2019년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2018-12-108

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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위치

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