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Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM

2016년 9월 2일 업데이트: Jaeb Center for Health Research

A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to <10 Year Olds)

The purpose of this study is to determine the efficacy, tolerability, safety, and effect on quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

On the day of enrollment, a hemoglobin A1c level will be obtained, and potential subjects will be evaluated for study eligibility through the elicitation of a medical history and performance of a physical examination by a study investigator.

The subject will return for a second visit about 6 weeks after the enrollment visit. At this visit, quality of life questionnaires will be completed and a CGM sensor will be inserted. The monitor will be blinded so that the glucose values cannot be seen. The parent will be instructed on insertion, calibration, and care of the CGM.

The subject will return for a randomization visit 14 to 28 days after the blinded CGM was initiated.

  • Subjects who have been compliant with use of the CGM and HGM will be randomized to one of two treatment groups: CGM Group or Control Group
  • For the CGM Group, the CGM, HGM, and pump data (if applicable) will be reviewed and changes will be made to diabetes management as needed. Parents will be taught to use the protocol-developed instructions for changes to diabetes management to be used in real time based on CGM and HGM data. Instructions for downloading the CGM and HGM will be provided to subjects with a home computer.
  • For the Control Group, a HGM and test strips will be provided. The HGM and pump data (if applicable) will be reviewed and changes will be made in diabetes management as needed. The blinded CGM data will be downloaded but will not be reviewed by study personnel until the end of the first 6 months of the study. Parents will be taught to use the protocol-developed instructions for how to make changes to diabetes management based on HGM data.

Both groups will have follow-up visits at 1,4,8,13,19, and 26 weeks (+/- 1 week) plus one contact between each visit (including one phone contact between the second visit and the one week visit) to review their diabetes management.

  • Both groups will download device data on a weekly basis (if the subject has a computer). Subjects with email access will be instructed to email the downloaded data to the clinical center prior to each phone contact.
  • For both groups, at each visit, the HGM and pump (if applicable) will be downloaded and for the CGM group, the CGM will be downloaded.

In the 13th and 26th weeks, the Control Group will use a blinded CGM for one week. The CGM Group will continue to use the blinded CGM. The Control Group will return the blinded CGM to the clinic after a week. The data will be reviewed by personnel who are not involved in the care of the subject to determine if additional blinded sensor data are needed. The blinded data will not be reviewed by the study personnel for management decisions until the end of the first 6 months of the study.

Following the 26-week visit:

  • Subjects in the RT-CGM Group will continue to use the CGM.
  • Subjects in the Control Group will be provided with a CGM and sensors after the week of blinded use and will have visits after 1 week and 4 weeks, with a phone contact during the first and second weeks.
  • Both groups will have visits after 13 weeks and 26 weeks

연구 유형

중재적

등록 (실제)

146

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 미국
    • California
      • Stanford, California, 미국, 94305
        • Stanford University Medical Center
    • Connecticut
      • New Haven, Connecticut, 미국, 06520
        • Yale University, School of Medicine
    • Florida
      • Jacksonville, Florida, 미국, 32207
        • Nemours Children's Clinic
    • Iowa
      • Iowa City, Iowa, 미국, 52242
        • Children's Hospital of Iowa, Department of Pediatrics
    • Missouri
      • St. Louis, Missouri, 미국, 63110
        • Washington University School of Medicine

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

4년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least twelve months
  2. Age >4.0 to <10.0 years
  3. HbA1c >= 7.0%
  4. Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) for the last three months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus (Glargine) insulin)

Exclusion Criteria:

  1. Diabetes diagnosed <6 months of age
  2. Use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.

  3. The presence of any of the following diseases or another disease that the investigator believes to be a contraindication to participation in the protocol:

    • Asthma if treated with systemic or daily inhaled corticosteroids in the last 6 months (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment)
    • Cystic fibrosis (Celiac disease and adequately treated thyroid disease do not exclude subjects from enrollment)
  4. Home use of CGM in past 6 months.
  5. Participation in an intervention study (including psychological studies) in past 6 weeks.
  6. Another member of the same household is participating in this study.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

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

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 1
continuous glucose monitoring
장치: 연속 포도당 모니터
연속 혈당 모니터의 매일 사용
다른 이름들:
  • FreeStyle Navigator
  • Medtronic Paradigm System
활성 비교기: 2
Standard glucose monitoring with a home glucose meter
장치: Home blood glucose monitor
Home monitoring 3 or more times a day
다른 이름들:
  • FreeStyle meter

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events
기간: 26 weeks
26 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Severe Hypoglycemic Events Experienced by Participants
기간: 26 weeks
26 weeks
CGM Glucose Values (mg/dL)
기간: 26 weeks
Percentage of sensors values in range (71 mg/dL to 180 mg/dL)
26 weeks
Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)
기간: 26 weeks
CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.
26 weeks
Measures of Variability: Standard Deviation (SD)
기간: 26 weeks
standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported.
26 weeks
Measures of Variability: Mean Absolute Rate of Change
기간: 26 weeks
mean absolute rate of change
26 weeks
Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)
기간: 26 weeks
Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55
26 weeks
Parental Quality of Life Measures: Hypoglycemia Fear Survey
기간: 26 weeks
The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0-100 with higher score denoting more fear. The results reported below are the values at 26 weeks.
26 weeks
Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)
기간: 26 weeks
The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks.
26 weeks
Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale
기간: 26 weeks
The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1-4. Higher score denotes fewer problems in the past month.
26 weeks
Parental Quality of Life Measures: CGM Satisfaction Scale
기간: 26 weeks

Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis)

JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679-684
26 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Jaeb Center for Health Research

협력자

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

수사관

  • 연구 의자: Roy W Beck, MD, PhD, Jaeb Center for Health Research

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

2010년 9월 1일

기본 완료 (실제)

2011년 6월 1일

연구 완료 (실제)

2012년 1월 1일

연구 등록 날짜

최초 제출

2008년 9월 25일

QC 기준을 충족하는 최초 제출

2008년 9월 25일

처음 게시됨 (추정)

2008년 9월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 10월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 9월 2일

마지막으로 확인됨

2016년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DirecNet 011
  • M01RR000069 (미국 NIH 보조금/계약)
  • HD041919-01,
  • HD041915-01,
  • HD041890,
  • HD041918-01,
  • HD041908-01,
  • HD041906-01,
  • RR00059,
  • RR 06022,
  • RR00070-41

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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