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Living Well with Diabetes + Remote Patient Monitoring for Type 2 Diabetes

Q: Does the enrollment period for this clinical trial still remain open?

<p>As per the information on clinicaltrials.gov, this trial is currently not in need of patient participants; it was initially posted to the public domain on October 18th 2022 and last updated November 14th 2022. Despite that fact, there are 1,395 other medical studies actively seeking enrolment presently.</p>

Q: What key goals is this clinical trial aiming to achieve?

<p>This research is assessing efficacy over a 9-month period. The primary outcome being measured is the Mean change in Hemoglobin A1c (HbA1c)%. Secondary objectives include tracking the Patient Activation Measure 13-Item Survey Score at 6 and 9 months after initiation of treatment, with higher values indicating better health outcomes.</p>

N/A

Waitlist Available

Led By Tracy Jalbuena, MD

Research Sponsored by Tracy Jalbuena MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after enrollment

Awards & highlights

Study Summary

This trial is testing whether RPM, which includes weekly check-ins and biometric monitoring, can help rural type 2 diabetics better manage their disease than usual care.

Eligible Conditions

Type 2 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean HbA1c%

Mean change in HbA1c%

Percentage of participants in each group who have HbA1c < 7%

Secondary outcome measures

Mean change in PAM-13 at 6 months

Mean change in PAM-13 at 9 months

PAM-13 at 6 months after enrollment

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Living Well with Diabetes + Remote Patient MonitoringExperimental Treatment1 Intervention

Remote patient monitoring as the intervention is defined as a tablet and Bluetooth-enabled glucometer technology that collects point-of-care (POC) blood glucose data from a patient outside of a traditional clinical setting, and securely transmits this data to Epic for review and potential intervention.

Group II: Living Well with DiabetesActive Control1 Intervention

Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program, PCP evaluation and management, including medication adjustment or interventions, and other types of interventions depending on clinical judgement. This may include eConsults between the provider and a pharmacist, in-person visits between the provider and the patient, synchronous telemedicine visits between the provider and the patient, and synchronous telemedicine visits between the pharmacist and the patient.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Remote Patient Monitoring

2012

Completed Phase 1

~2510

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MaineHealthOTHER

71 Previous Clinical Trials

49,307 Total Patients Enrolled

Tracy Jalbuena MDLead Sponsor

Health Resources and Services Administration (HRSA)FED

84 Previous Clinical Trials

151,487 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the enrollment period for this clinical trial still remain open?

"As per the information on clinicaltrials.gov, this trial is currently not in need of patient participants; it was initially posted to the public domain on October 18th 2022 and last updated November 14th 2022. Despite that fact, there are 1,395 other medical studies actively seeking enrolment presently."

Answered by AI

What key goals is this clinical trial aiming to achieve?

"This research is assessing efficacy over a 9-month period. The primary outcome being measured is the Mean change in Hemoglobin A1c (HbA1c)%. Secondary objectives include tracking the Patient Activation Measure 13-Item Survey Score at 6 and 9 months after initiation of treatment, with higher values indicating better health outcomes."

Answered by AI

Recent research and studies

Population Health MetricsJournal

Projection of the Year 2050 Burden of Diabetes in the US Adult Population: Dynamic Modeling of Incidence, Mortality, and Prediabetes Prevalence

Boyle, James P, Theodore J Thompson, Edward W Gregg, Lawrence E Barker, and David F Williamson. 2010. “Projection of the Year 2050 Burden of Diabetes in the US Adult Population: Dynamic Modeling of Incidence, Mortality, and Prediabetes Prevalence”. Population Health Metrics. Springer Science and Business Media LLC. doi:10.1186/1478-7954-8-29.

Journal of General Internal MedicineJournal

Why Does Patient Activation Matter? an Examination of the Relationships Between Patient Activation and Health-related Outcomes

Greene, Jessica, and Judith H. Hibbard. 2011. “Why Does Patient Activation Matter? an Examination of the Relationships Between Patient Activation and Health-related Outcomes”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1007/s11606-011-1931-2.

Journal of Ambulatory Care ManagementJournal

Assessing Activation Stage and Employing a “next Steps

Hibbard, Judith H., and Martin Tusler. 2007. “Assessing Activation Stage and Employing a “next Steps” Approach to Supporting Patient Self-management”. Journal of Ambulatory Care Management. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00004479-200701000-00002.

BmjJournal