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

8. maj 2019 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

328

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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;

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline to end of study (Month 6) in HbA1c levels
Tidsramme: 6 months
Assessed from blood samples taken at visits per standard of care
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of patients who achieve HbA1c levels <7% at Month 6
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 Months
Defined as an increase in dose or addition of a new antihyperglycemic agent not received at baseline
6 Months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of times the smart phone- and/or web portal-based tool is accessed per patient
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 Months
Assessed by the User Satisfaction Survey
6 Months
Mean percent change from baseline to Month 6 in systolic blood pressure
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 6 Months
As assessed in the Patient Reported Outcome measure Morisky Medication Adherence Scale at the point-of-care visits
6 Months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Efterforskere

  • Studiestol: Kevin Sooben, AstraZeneca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. maj 2017

Primær færdiggørelse (Faktiske)

21. maj 2018

Studieafslutning (Faktiske)

21. maj 2018

Datoer for studieregistrering

Først indsendt

20. marts 2017

Først indsendt, der opfyldte QC-kriterier

20. marts 2017

Først opslået (Faktiske)

24. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D1841C00004

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Kliniske forsøg med Type 2 diabetes mellitus

Kliniske forsøg med Use of digital disease management tool

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Betingelser

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