A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
8 mei 2019 bijgewerkt door: 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
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
328
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35209
- Research Site
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Birmingham, Alabama, Verenigde Staten, 35216
- Research Site
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Arizona
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Peoria, Arizona, Verenigde Staten, 85381
- Research Site
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Surprise, Arizona, Verenigde Staten, 85374
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California
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Lincoln, California, Verenigde Staten, 95648
- Research Site
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Montclair, California, Verenigde Staten, 91763
- Resezrch Site
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North Hollywood, California, Verenigde Staten, 91606
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Spring Valley, California, Verenigde Staten, 91978
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Van Nuys, California, Verenigde Staten, 91405
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80906
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Florida
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Cooper City, Florida, Verenigde Staten, 33024
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DeLand, Florida, Verenigde Staten, 32720
- Research Site
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Hialeah, Florida, Verenigde Staten, 33012
- Research Site
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Jacksonville, Florida, Verenigde Staten, 32277
- Reserarch Site
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Lake City, Florida, Verenigde Staten, 32055
- Research Site
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Ormond Beach, Florida, Verenigde Staten, 32174
- Research Site
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Pembroke Pines, Florida, Verenigde Staten, 33026
- Research Site
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Port Orange, Florida, Verenigde Staten, 32127
- Research Site
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Tampa, Florida, Verenigde Staten, 33634
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Illinois
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Evanston, Illinois, Verenigde Staten, 60201
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40503
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Maryland
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Oxon Hill, Maryland, Verenigde Staten, 20745
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68134
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89128
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87102
- Research Site
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New York
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Brooklyn, New York, Verenigde Staten, 11235
- Research Site
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New Windsor, New York, Verenigde Staten, 12553
- Research Site
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Westfield, New York, Verenigde Staten, 14787
- Research Site
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North Carolina
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Greensboro, North Carolina, Verenigde Staten, 27410
- Research Site
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Ohio
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Franklin, Ohio, Verenigde Staten, 45005
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Pennsylvania
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Downingtown, Pennsylvania, Verenigde Staten, 19335
- Research Site
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29407
- Research Site
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Greer, South Carolina, Verenigde Staten, 29651
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Myrtle Beach, South Carolina, Verenigde Staten, 29588
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Spartanburg, South Carolina, Verenigde Staten, 29301
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Tennessee
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Tullahoma, Tennessee, Verenigde Staten, 37388
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Texas
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Houston, Texas, Verenigde Staten, 77058
- Research Site
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Houston, Texas, Verenigde Staten, 77040
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Lampasas, Texas, Verenigde Staten, 76550
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Plano, Texas, Verenigde Staten, 75024
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84107
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Virginia
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Burke, Virginia, Verenigde Staten, 22015
- Research Site
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Manassas, Virginia, Verenigde Staten, 20110
- Research Site
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Richmond, Virginia, Verenigde Staten, 23235
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Washington
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Federal Way, Washington, Verenigde Staten, 98003
- Research Site
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Olympia, Washington, Verenigde Staten, 98502
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 99 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
Beschrijving
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;
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Standard of Care (SOC)
Participants have standard of care with no access to digital disease management tool
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SOC + digital disease management
Participants have access to the digital disease management tool in addition to standard of care
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline to end of study (Month 6) in HbA1c levels
Tijdsspanne: 6 months
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Assessed from blood samples taken at visits per standard of care
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6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of patients who achieve HbA1c levels <7% at Month 6
Tijdsspanne: 6 Months
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Assessed from blood samples taken at visits per standard of care
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6 Months
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Mean change in body weight (kg) from baseline to Month 6
Tijdsspanne: 6 Months
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Measures taken at visits per standard of care
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6 Months
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Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1
Tijdsspanne: 6 Months
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Defined as an increase in dose or addition of a new antihyperglycemic agent not received at baseline
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6 Months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of times the smart phone- and/or web portal-based tool is accessed per patient
Tijdsspanne: 6 Months
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Calculated by adding the total number of discrete log-in attempts to the tool for each patient using the tool at least once
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6 Months
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Length of time from first to last usage of smart phone- and/or web portal-based tool across the course of the study
Tijdsspanne: 6 Months
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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
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6 Months
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Mean patient satisfaction with the digital disease management tool
Tijdsspanne: 6 Months
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Assessed by the User Satisfaction Survey
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6 Months
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Mean percent change from baseline to Month 6 in systolic blood pressure
Tijdsspanne: 6 Months
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Measures taken at visits per standard of care
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6 Months
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Mean percent change from baseline to Month 6 in low-density lipoprotein-cholesterol (LDL-C)
Tijdsspanne: 6 Months
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Assessed from blood samples taken at visits per standard of care
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6 Months
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Percent of patients who achieve blood pressure <140/90 mmHg at Month 6
Tijdsspanne: 6 Months
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Measures taken at visits per standard of care
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6 Months
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Percent of patients who achieve LDL-C <100 mg/dL at Month 6
Tijdsspanne: 6 Months
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Assessed from blood samples taken at visits per standard of care
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6 Months
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Differences in primary care office visits between active and control group during the 6-month study period
Tijdsspanne: 6 Months
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As reported in patient records
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6 Months
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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
Tijdsspanne: 6 Months
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As reported by patients at the end of the study
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6 Months
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Change in baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version score
Tijdsspanne: 6 Months
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As assessed in the Patient Reported Outcome measure Diabetes Treatment Satisfaction Questionnaire - Status version at the point-of-care visits
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6 Months
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Change in baseline to Month 6 in Diabetes Self-Management Questionnaire score (16-question) (patient perception on ability to manage their disease)
Tijdsspanne: 6 Months
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As assessed in the Patient Reported Outcomes measure Diabetes Self-Management Questionnaire at the point-of-care visits
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6 Months
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Change in baseline to Month 6 in Morisky Medication Adherence Scale (8-item) (adherence)
Tijdsspanne: 6 Months
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As assessed in the Patient Reported Outcome measure Morisky Medication Adherence Scale at the point-of-care visits
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6 Months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Kevin Sooben, AstraZeneca
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
8 mei 2017
Primaire voltooiing (Werkelijk)
21 mei 2018
Studie voltooiing (Werkelijk)
21 mei 2018
Studieregistratiedata
Eerst ingediend
20 maart 2017
Eerst ingediend dat voldeed aan de QC-criteria
20 maart 2017
Eerst geplaatst (Werkelijk)
24 maart 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 mei 2019
Laatste update ingediend die voldeed aan QC-criteria
8 mei 2019
Laatst geverifieerd
1 mei 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D1841C00004
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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