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eConsult for Diabetes

N/A

Waitlist Available

Led By Devin Steenkamp, MD

Research Sponsored by Boston Medical Center

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 baseline, 3, 6, and 12 months

Awards & highlights

Study Summary

This trial is testing whether getting eConsults (a remote consultation with a specialist using technology) for diabetes care is non-inferior to in-person visits with a specialist.

Eligible Conditions

Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Glycemic control based on A1c

Hemoglobin A1c (A1c) at 12 months

Hemoglobin A1c (A1c) at 3 months

+6 more

Secondary outcome measures

Cost effectiveness analysis (CEA)

Efficacy of embedded clinical pharmacists

Number of clinical visits for diabetes care

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Freestyle Libre sensor armExperimental Treatment1 Intervention

In this arm, patients meeting eligibility criteria and consented into the study are randomized to have the Freestyle Libre Pro continuous glucose monitor (CGM) placed at their primary care clinic. The data collected from the diagnostic CGM will be utilized in conjunction with diet, exercise and medication logs provided by the patient and information from the patient's electronic medical record to complete an eConsult with treatment recommendations. Implementation of these recommendations will be per the primary care provider's discretion in conjunction with conversation with the patient in follow up visits. Surveys will be administered to measure patient burden and self efficacy.

Group II: In-person visit armActive Control1 Intervention

In this arm, patients meeting eligibility criteria and consented into the study are randomized to an in-person visit with an Endocrinologist. This is currently the standard of care for patients referred for diabetes specialty care. Care by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences. Surveys will be administered to measure patient burden and self efficacy.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor

383 Previous Clinical Trials

871,062 Total Patients Enrolled

2 Trials studying Diabetes

12 Patients Enrolled for Diabetes

Devin Steenkamp, MDPrincipal InvestigatorBoston Medical Center, Endocrinology, Diabetes & Nutrition

Frequently Asked Questions

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

What objectives does this investigation seek to accomplish?

"The primary endpoint of this trial as measured over baseline and 12 months is the A1c level at baseline. Secondary outcomes include a modified assessment of patient-perceived research burden, provider acceptability assessed through 16 items on Likert scale from 1 to 5, and efficacy of embedded clinical pharmacists judged by changes in Hemoglobin A1C levels."

Answered by AI

Is enrollment open to applicants for this study?

"Unfortunately, clinicaltrials.gov has determined that this particular trial is not accepting new candidates at the moment; however, it was initially posted on February 3rd 2020 and last edited on 22nd of February 2022. Nevertheless, there are 1275 other trials actively enrolling participants."

Answered by AI

Am I eligible for enrollment in this study?

"This diabetes study seeks 152 volunteers aged 18-80 who are able to communicate in English and meet the following specific criteria: A recent referral from primary care, Unseen by endocrinology for 3 years or longer, Diagnosed with T2D at least 6 months before screening, Willingness to complete surveys provided, Ability to use an Abbott® FreeStyle Libre Pro device over 7-14 days."

Answered by AI

Are elderly patients excluded from this investigation?

"This clinical trial is only open to those between 18-80 years of age. Concurrently, there are 200 studies for minors and 958 dedicated to seniors over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diabetes eConsult Non-Inferiority Study

2020. "Diabetes eConsult Non-Inferiority Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04089202.