A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
8 maggio 2019 aggiornato da: 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
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
328
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35209
- Research Site
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Birmingham, Alabama, Stati Uniti, 35216
- Research Site
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Arizona
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Peoria, Arizona, Stati Uniti, 85381
- Research Site
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Surprise, Arizona, Stati Uniti, 85374
- Research Site
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California
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Lincoln, California, Stati Uniti, 95648
- Research Site
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Montclair, California, Stati Uniti, 91763
- Resezrch Site
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North Hollywood, California, Stati Uniti, 91606
- Research Site
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Spring Valley, California, Stati Uniti, 91978
- Research Site
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Van Nuys, California, Stati Uniti, 91405
- Research Site
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80906
- Research Site
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Florida
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Cooper City, Florida, Stati Uniti, 33024
- Research Site
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DeLand, Florida, Stati Uniti, 32720
- Research Site
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Hialeah, Florida, Stati Uniti, 33012
- Research Site
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Jacksonville, Florida, Stati Uniti, 32277
- Reserarch Site
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Lake City, Florida, Stati Uniti, 32055
- Research Site
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Ormond Beach, Florida, Stati Uniti, 32174
- Research Site
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Pembroke Pines, Florida, Stati Uniti, 33026
- Research Site
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Port Orange, Florida, Stati Uniti, 32127
- Research Site
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Tampa, Florida, Stati Uniti, 33634
- Research Site
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Illinois
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Evanston, Illinois, Stati Uniti, 60201
- Research Site
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40503
- Research Site
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Maryland
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Oxon Hill, Maryland, Stati Uniti, 20745
- Research Site
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68134
- Research Site
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89128
- Research Site
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
- Research Site
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New York
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Brooklyn, New York, Stati Uniti, 11235
- Research Site
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New Windsor, New York, Stati Uniti, 12553
- Research Site
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Westfield, New York, Stati Uniti, 14787
- Research Site
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North Carolina
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Greensboro, North Carolina, Stati Uniti, 27410
- Research Site
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Ohio
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Franklin, Ohio, Stati Uniti, 45005
- Research Site
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Pennsylvania
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Downingtown, Pennsylvania, Stati Uniti, 19335
- Research Site
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29407
- Research Site
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Greer, South Carolina, Stati Uniti, 29651
- Research Site
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Myrtle Beach, South Carolina, Stati Uniti, 29588
- Research Site
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Spartanburg, South Carolina, Stati Uniti, 29301
- Research Site
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Tennessee
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Tullahoma, Tennessee, Stati Uniti, 37388
- Research Site
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Texas
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Houston, Texas, Stati Uniti, 77058
- Research Site
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Houston, Texas, Stati Uniti, 77040
- Research Site
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Lampasas, Texas, Stati Uniti, 76550
- Research Site
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Plano, Texas, Stati Uniti, 75024
- Research Site
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Utah
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Salt Lake City, Utah, Stati Uniti, 84107
- Research Site
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Virginia
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Burke, Virginia, Stati Uniti, 22015
- Research Site
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Manassas, Virginia, Stati Uniti, 20110
- Research Site
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Richmond, Virginia, Stati Uniti, 23235
- Research Site
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Washington
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Federal Way, Washington, Stati Uniti, 98003
- Research Site
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Olympia, Washington, Stati Uniti, 98502
- Research Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 99 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
Descrizione
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;
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline to end of study (Month 6) in HbA1c levels
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of patients who achieve HbA1c levels <7% at Month 6
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of times the smart phone- and/or web portal-based tool is accessed per patient
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Cattedra di studio: Kevin Sooben, AstraZeneca
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
8 maggio 2017
Completamento primario (Effettivo)
21 maggio 2018
Completamento dello studio (Effettivo)
21 maggio 2018
Date di iscrizione allo studio
Primo inviato
20 marzo 2017
Primo inviato che soddisfa i criteri di controllo qualità
20 marzo 2017
Primo Inserito (Effettivo)
24 marzo 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 maggio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 maggio 2019
Ultimo verificato
1 maggio 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D1841C00004
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .