A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
8 maj 2019 uppdaterad av: 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
328
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35209
- Research Site
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Birmingham, Alabama, Förenta staterna, 35216
- Research Site
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Arizona
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Peoria, Arizona, Förenta staterna, 85381
- Research Site
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Surprise, Arizona, Förenta staterna, 85374
- Research Site
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California
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Lincoln, California, Förenta staterna, 95648
- Research Site
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Montclair, California, Förenta staterna, 91763
- Resezrch Site
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North Hollywood, California, Förenta staterna, 91606
- Research Site
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Spring Valley, California, Förenta staterna, 91978
- Research Site
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Van Nuys, California, Förenta staterna, 91405
- Research Site
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80906
- Research Site
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Florida
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Cooper City, Florida, Förenta staterna, 33024
- Research Site
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DeLand, Florida, Förenta staterna, 32720
- Research Site
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Hialeah, Florida, Förenta staterna, 33012
- Research Site
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Jacksonville, Florida, Förenta staterna, 32277
- Reserarch Site
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Lake City, Florida, Förenta staterna, 32055
- Research Site
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Ormond Beach, Florida, Förenta staterna, 32174
- Research Site
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Pembroke Pines, Florida, Förenta staterna, 33026
- Research Site
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Port Orange, Florida, Förenta staterna, 32127
- Research Site
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Tampa, Florida, Förenta staterna, 33634
- Research Site
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Illinois
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Evanston, Illinois, Förenta staterna, 60201
- Research Site
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40503
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Maryland
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Oxon Hill, Maryland, Förenta staterna, 20745
- Research Site
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68134
- Research Site
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89128
- Research Site
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87102
- Research Site
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New York
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Brooklyn, New York, Förenta staterna, 11235
- Research Site
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New Windsor, New York, Förenta staterna, 12553
- Research Site
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Westfield, New York, Förenta staterna, 14787
- Research Site
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North Carolina
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Greensboro, North Carolina, Förenta staterna, 27410
- Research Site
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Ohio
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Franklin, Ohio, Förenta staterna, 45005
- Research Site
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Pennsylvania
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Downingtown, Pennsylvania, Förenta staterna, 19335
- Research Site
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29407
- Research Site
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Greer, South Carolina, Förenta staterna, 29651
- Research Site
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Myrtle Beach, South Carolina, Förenta staterna, 29588
- Research Site
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Spartanburg, South Carolina, Förenta staterna, 29301
- Research Site
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Tennessee
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Tullahoma, Tennessee, Förenta staterna, 37388
- Research Site
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Texas
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Houston, Texas, Förenta staterna, 77058
- Research Site
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Houston, Texas, Förenta staterna, 77040
- Research Site
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Lampasas, Texas, Förenta staterna, 76550
- Research Site
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Plano, Texas, Förenta staterna, 75024
- Research Site
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Utah
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Salt Lake City, Utah, Förenta staterna, 84107
- Research Site
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Virginia
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Burke, Virginia, Förenta staterna, 22015
- Research Site
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Manassas, Virginia, Förenta staterna, 20110
- Research Site
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Richmond, Virginia, Förenta staterna, 23235
- Research Site
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Washington
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Federal Way, Washington, Förenta staterna, 98003
- Research Site
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Olympia, Washington, Förenta staterna, 98502
- Research Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 99 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline to end of study (Month 6) in HbA1c levels
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Percentage of patients who achieve HbA1c levels <7% at Month 6
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of times the smart phone- and/or web portal-based tool is accessed per patient
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Kevin Sooben, AstraZeneca
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 maj 2017
Primärt slutförande (Faktisk)
21 maj 2018
Avslutad studie (Faktisk)
21 maj 2018
Studieregistreringsdatum
Först inskickad
20 mars 2017
Först inskickad som uppfyllde QC-kriterierna
20 mars 2017
Första postat (Faktisk)
24 mars 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 maj 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 maj 2019
Senast verifierad
1 maj 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- D1841C00004
Plan för individuella deltagardata (IPD)
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