A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
8 mai 2019 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
328
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35209
- Research Site
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Birmingham, Alabama, États-Unis, 35216
- Research Site
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Arizona
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Peoria, Arizona, États-Unis, 85381
- Research Site
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Surprise, Arizona, États-Unis, 85374
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California
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Lincoln, California, États-Unis, 95648
- Research Site
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Montclair, California, États-Unis, 91763
- Resezrch Site
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North Hollywood, California, États-Unis, 91606
- Research Site
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Spring Valley, California, États-Unis, 91978
- Research Site
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Van Nuys, California, États-Unis, 91405
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Colorado
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Colorado Springs, Colorado, États-Unis, 80906
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Florida
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Cooper City, Florida, États-Unis, 33024
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DeLand, Florida, États-Unis, 32720
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Hialeah, Florida, États-Unis, 33012
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Jacksonville, Florida, États-Unis, 32277
- Reserarch Site
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Lake City, Florida, États-Unis, 32055
- Research Site
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Ormond Beach, Florida, États-Unis, 32174
- Research Site
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Pembroke Pines, Florida, États-Unis, 33026
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Port Orange, Florida, États-Unis, 32127
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Tampa, Florida, États-Unis, 33634
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Illinois
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Evanston, Illinois, États-Unis, 60201
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Kentucky
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Lexington, Kentucky, États-Unis, 40503
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Maryland
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Oxon Hill, Maryland, États-Unis, 20745
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Nebraska
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Omaha, Nebraska, États-Unis, 68134
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Nevada
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Las Vegas, Nevada, États-Unis, 89128
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87102
- Research Site
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New York
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Brooklyn, New York, États-Unis, 11235
- Research Site
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New Windsor, New York, États-Unis, 12553
- Research Site
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Westfield, New York, États-Unis, 14787
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North Carolina
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Greensboro, North Carolina, États-Unis, 27410
- Research Site
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Ohio
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Franklin, Ohio, États-Unis, 45005
- Research Site
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Pennsylvania
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Downingtown, Pennsylvania, États-Unis, 19335
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South Carolina
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Charleston, South Carolina, États-Unis, 29407
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Greer, South Carolina, États-Unis, 29651
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Myrtle Beach, South Carolina, États-Unis, 29588
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Spartanburg, South Carolina, États-Unis, 29301
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Tennessee
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Tullahoma, Tennessee, États-Unis, 37388
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Texas
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Houston, Texas, États-Unis, 77058
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Houston, Texas, États-Unis, 77040
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Lampasas, Texas, États-Unis, 76550
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Plano, Texas, États-Unis, 75024
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Utah
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Salt Lake City, Utah, États-Unis, 84107
- Research Site
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Virginia
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Burke, Virginia, États-Unis, 22015
- Research Site
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Manassas, Virginia, États-Unis, 20110
- Research Site
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Richmond, Virginia, États-Unis, 23235
- Research Site
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Washington
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Federal Way, Washington, États-Unis, 98003
- Research Site
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Olympia, Washington, États-Unis, 98502
- Research Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 99 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
La description
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;
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline to end of study (Month 6) in HbA1c levels
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of patients who achieve HbA1c levels <7% at Month 6
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of times the smart phone- and/or web portal-based tool is accessed per patient
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Kevin Sooben, AstraZeneca
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 mai 2017
Achèvement primaire (Réel)
21 mai 2018
Achèvement de l'étude (Réel)
21 mai 2018
Dates d'inscription aux études
Première soumission
20 mars 2017
Première soumission répondant aux critères de contrôle qualité
20 mars 2017
Première publication (Réel)
24 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 mai 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mai 2019
Dernière vérification
1 mai 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D1841C00004
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .