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A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM

2019년 5월 8일 업데이트: AstraZeneca

A Real-world, Point-of-care, Randomized, Parallel Group, Open, 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes mellitus is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus. The purpose of this study is to evaluate if the use of a digital disease management tool (Smart phone- web portal-based tool), in addition to Standard of Care for T2DM, will improve glycemic control. Other variables important in T2DM (such as weight, blood pressure, and lipid levels), will also be evaluated along with patient-reported outcomes, such as satisfaction with treatment and adherence to their antihyperglycemic treatment. Study duration is 6 months

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Type 2 diabetes mellitus (T2DM) is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus. A digital disease-management tool, smart phone- and web-based portal, has been developed that incorporates the following features aimed at improving patient and population outcomes:

Treatment management to help patients remember to take medications and track adherence; Goal setting, including medical nutrition therapy, appropriately prescribed physical activity, and weight loss for those patients who are overweight or obese; Tracking and data collection for blood glucose, weight, and exercise, as entered by the patient or automatically for activity via Bluetooth pedometer or activity tracker; Assessments to capture patient beliefs in order to tailor personalized content to individual needs; educational and motivational content in the form of short messages, text, and videos covering T2DM and its treatment, and lifestyle advice; Web portals to display collected data back to the patient and healthcare practitioner in real-time to allow better and timely management of diabetes.

This tool is added to the Standard of Care for T2DM. Data are collected for patients utilizing this tool, compared with those who are not. Clinical assessments as part of the Standard of Care are collected, as well as standard Patient Reported Outcomes for this disease.

Glycemic control is considered to be the goal of a T2DM disease management plan.

연구 유형

관찰

등록 (실제)

328

연락처 및 위치

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

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35209
        • Research Site
      • Birmingham, Alabama, 미국, 35216
        • Research Site
    • Arizona
      • Peoria, Arizona, 미국, 85381
        • Research Site
      • Surprise, Arizona, 미국, 85374
        • Research Site
    • California
      • Lincoln, California, 미국, 95648
        • Research Site
      • Montclair, California, 미국, 91763
        • Resezrch Site
      • North Hollywood, California, 미국, 91606
        • Research Site
      • Spring Valley, California, 미국, 91978
        • Research Site
      • Van Nuys, California, 미국, 91405
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, 미국, 80906
        • Research Site
    • Florida
      • Cooper City, Florida, 미국, 33024
        • Research Site
      • DeLand, Florida, 미국, 32720
        • Research Site
      • Hialeah, Florida, 미국, 33012
        • Research Site
      • Jacksonville, Florida, 미국, 32277
        • Reserarch Site
      • Lake City, Florida, 미국, 32055
        • Research Site
      • Ormond Beach, Florida, 미국, 32174
        • Research Site
      • Pembroke Pines, Florida, 미국, 33026
        • Research Site
      • Port Orange, Florida, 미국, 32127
        • Research Site
      • Tampa, Florida, 미국, 33634
        • Research Site
    • Illinois
      • Evanston, Illinois, 미국, 60201
        • Research Site
    • Kentucky
      • Lexington, Kentucky, 미국, 40503
        • Research Site
    • Maryland
      • Oxon Hill, Maryland, 미국, 20745
        • Research Site
    • Nebraska
      • Omaha, Nebraska, 미국, 68134
        • Research Site
    • Nevada
      • Las Vegas, Nevada, 미국, 89128
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87102
        • Research Site
    • New York
      • Brooklyn, New York, 미국, 11235
        • Research Site
      • New Windsor, New York, 미국, 12553
        • Research Site
      • Westfield, New York, 미국, 14787
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, 미국, 27410
        • Research Site
    • Ohio
      • Franklin, Ohio, 미국, 45005
        • Research Site
    • Pennsylvania
      • Downingtown, Pennsylvania, 미국, 19335
        • Research Site
    • South Carolina
      • Charleston, South Carolina, 미국, 29407
        • Research Site
      • Greer, South Carolina, 미국, 29651
        • Research Site
      • Myrtle Beach, South Carolina, 미국, 29588
        • Research Site
      • Spartanburg, South Carolina, 미국, 29301
        • Research Site
    • Tennessee
      • Tullahoma, Tennessee, 미국, 37388
        • Research Site
    • Texas
      • Houston, Texas, 미국, 77058
        • Research Site
      • Houston, Texas, 미국, 77040
        • Research Site
      • Lampasas, Texas, 미국, 76550
        • Research Site
      • Plano, Texas, 미국, 75024
        • Research Site
    • Utah
      • Salt Lake City, Utah, 미국, 84107
        • Research Site
    • Virginia
      • Burke, Virginia, 미국, 22015
        • Research Site
      • Manassas, Virginia, 미국, 20110
        • Research Site
      • Richmond, Virginia, 미국, 23235
        • Research Site
    • Washington
      • Federal Way, Washington, 미국, 98003
        • Research Site
      • Olympia, Washington, 미국, 98502
        • Research Site

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

샘플링 방법

확률 샘플

연구 인구

Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.

설명

Inclusion Criteria:

  • Provision of written informed consent;
  • Diagnosed with T2DM;
  • Male or female aged >/= 18 years at time of consent;
  • Treatment with 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment;
  • Own or have access to a smart phone with internet access and have access to the internet via a tablet or personal computer at least once a day;
  • HbA1c levels must be obtained at the enrollment visit or up to 14 days prior to Visit 1 and must be >/=7.5% and </=11.0%. Most of the hbA1c values obtained within the past 9 months must also be within this range;
  • Body mass index >/= 25 and </=55 kg/mm2 within the last 3 months;
  • Ability to communicate in English;
  • Judged by their primary care physician to have suitable hearing, vision, manual dexterity, ability to understand instructions, and ability to use and understand smart phone and internet applications;
  • Negative pregnancy test for female subjects of childbearing potential.

Exclusion Criteria:

  • Pregnancy;
  • Insulin use at baseline;
  • Current use of a smart phone- or web portal-based tool designed to help with management of T2DM;
  • History of Type 1 diabetes or ketoacidosis;
  • Currently taking weight loss medication;
  • Involvement in the planning and/or conduct of this study;
  • Previous enrollment in the present study;
  • Participation in a clinical study with an investigational product or a disease state management program during the last 30 days;

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Standard of Care (SOC)
Participants have standard of care with no access to digital disease management tool
SOC + digital disease management
Participants have access to the digital disease management tool in addition to standard of care
다른: Use of digital disease management tool
The purpose of the study is to evaluate if the provision of a digital disease management tool, in addition to SOC for T2DM, will improve glycemic control. The impact of the tool will be assessed in comparison to a Control group who will receive SOC alone. All participants will complete the PRO assessments. This is a real world study carried out at the point of care.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline to end of study (Month 6) in HbA1c levels
기간: 6 months
Assessed from blood samples taken at visits per standard of care
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of patients who achieve HbA1c levels <7% at Month 6
기간: 6 Months
Assessed from blood samples taken at visits per standard of care
6 Months
Mean change in body weight (kg) from baseline to Month 6
기간: 6 Months
Measures taken at visits per standard of care
6 Months
Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1
기간: 6 Months
Defined as an increase in dose or addition of a new antihyperglycemic agent not received at baseline
6 Months

기타 결과 측정

결과 측정
측정값 설명
기간
Number of times the smart phone- and/or web portal-based tool is accessed per patient
기간: 6 Months
Calculated by adding the total number of discrete log-in attempts to the tool for each patient using the tool at least once
6 Months
Length of time from first to last usage of smart phone- and/or web portal-based tool across the course of the study
기간: 6 Months
Determined by calculating the time from first to last log-in attempt for each patient accessing the tool at least twice during the course of the study
6 Months
Mean patient satisfaction with the digital disease management tool
기간: 6 Months
Assessed by the User Satisfaction Survey
6 Months
Mean percent change from baseline to Month 6 in systolic blood pressure
기간: 6 Months
Measures taken at visits per standard of care
6 Months
Mean percent change from baseline to Month 6 in low-density lipoprotein-cholesterol (LDL-C)
기간: 6 Months
Assessed from blood samples taken at visits per standard of care
6 Months
Percent of patients who achieve blood pressure <140/90 mmHg at Month 6
기간: 6 Months
Measures taken at visits per standard of care
6 Months
Percent of patients who achieve LDL-C <100 mg/dL at Month 6
기간: 6 Months
Assessed from blood samples taken at visits per standard of care
6 Months
Differences in primary care office visits between active and control group during the 6-month study period
기간: 6 Months
As reported in patient records
6 Months
Differences in Emergency Room visits between active and control group during the 6-month study period as reported in patients at the end of the study
기간: 6 Months
As reported by patients at the end of the study
6 Months
Change in baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version score
기간: 6 Months
As assessed in the Patient Reported Outcome measure Diabetes Treatment Satisfaction Questionnaire - Status version at the point-of-care visits
6 Months
Change in baseline to Month 6 in Diabetes Self-Management Questionnaire score (16-question) (patient perception on ability to manage their disease)
기간: 6 Months
As assessed in the Patient Reported Outcomes measure Diabetes Self-Management Questionnaire at the point-of-care visits
6 Months
Change in baseline to Month 6 in Morisky Medication Adherence Scale (8-item) (adherence)
기간: 6 Months
As assessed in the Patient Reported Outcome measure Morisky Medication Adherence Scale at the point-of-care visits
6 Months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

수사관

  • 연구 의자: Kevin Sooben, AstraZeneca

간행물 및 유용한 링크

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

유용한 링크

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)

2017년 5월 8일

기본 완료 (실제)

2018년 5월 21일

연구 완료 (실제)

2018년 5월 21일

연구 등록 날짜

최초 제출

2017년 3월 20일

QC 기준을 충족하는 최초 제출

2017년 3월 20일

처음 게시됨 (실제)

2017년 3월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 5월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 5월 8일

마지막으로 확인됨

2019년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D1841C00004

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

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. .

구독하다