Diabetes eConsult Non-Inferiority Study

February 22, 2023 updated by: Boston Medical Center

Comparing Electronic Versus In-Person Access to Specialty Diabetes Expertise

Flash glucose monitoring is an FDA-approved and widely clinically available, glucose monitoring technology that is worn on the body and measures glucose values every 15 minutes, storing this data for up to 14 days. The Freestyle Libre Pro is already used as a diagnostic technology in clinical care. It provides a full 24-hour glucose profile for each day that the sensor is worn and that can be correlated with daily activities, medication administration, food intake, and other factors that are contextually relevant in meeting glycemic goals for an individual patient.

In this study, patients referred to Endocrinology for specialty diabetes care will be randomized to an in-person visit as is typically done or to wear the Freestyle Libre Pro placed by staff at their primary care clinic. Patients who wear the Freestyle Libre Pro will have a professional interpretation of their glucose data completed by an endocrinologist as well as a remote eConsult completed using this glucose data and information from their medical record. The recommendations from the eConsult regarding medication and lifestyle adjustment as well as potential referral on to see Endocrinology will be implemented by the primary care physician at their clinical discretion.

The investigators will utilize glycemic measures including hemoglobin A1c, number of clinical visits (outpatient, inpatient and emergency department) for diabetes care, patient reported outcomes including self-efficacy, and patient and provider assessments of burden to determine if eConsults utilizing flash glucose monitoring technology are non-inferior to in-person visits with a diabetes specialist.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects age 18-80, inclusive
  • Diagnosed with type 2 diabetes at least 6 months prior to screening
  • Not previously seen within the prior three years in the endocrinology clinic for diabetes management
  • Referred to endocrinology for diabetes care directly from primary care
  • Willing to wear an Abbott® FreeStyle Libre Pro for 7-14 days
  • English speaking
  • Able and willing to complete questionnaires

Exclusion Criteria:

  • Planned travel or surgery during the time of libre wear
  • Patients without a diagnosis of type 2 diabetes, including individuals with type 1 diabetes and gestational diabetes
  • Women referred for diabetes care during pregnancy, or while breastfeeding or who intend to become pregnant during involvement in this trial
  • Currently using real time CGM or FGM system
  • Concurrent involvement in another clinical trial using diabetes pharmacotherapy
  • Individuals with active malignancy undergoing treatment with chemotherapy and/or high dose glucocorticoids
  • Individuals with rheumatic disease undergoing treatment with high dose glucocorticoids
  • Planned magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment during the time of Libre wear
  • Any cognitive or other disorders, in the investigator's opinion, that may interfere with participation or ability to follow the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: In-person visit arm

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.
Other: Standard of care
Care by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences.
Experimental: Freestyle Libre sensor arm

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.
Other: eConsult
Completion of electronic consult utilizing data collected from flash glucose monitoring

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (A1c) at baseline
Time Frame: baseline
A1c will be obtained as standard of care and values documented in the medical record.
baseline
Hemoglobin A1c (A1c) at 3 months
Time Frame: 3 months
A1c will be obtained as standard of care and values documented in the medical record.
3 months
Hemoglobin A1c (A1c) at 6 months
Time Frame: 6 months
A1c will be obtained as standard of care and values documented in the medical record.
6 months
Hemoglobin A1c (A1c) at 12 months
Time Frame: 12 months
A1c will be obtained as standard of care and values documented in the medical record.
12 months
Percentage change in A1c to 6 months
Time Frame: baseline, 6 months
The percent change in A1c will be calculated from baseline to six months
baseline, 6 months
Percentage change in A1c to 12 months
Time Frame: baseline, 12 months
The percent change in A1c will be calculated from baseline to 12 months
baseline, 12 months
Proportion of patients with A1c <7%
Time Frame: 6 months, 12 months
The proportion of participants with A1c <7% (ADA target) will be calculated.
6 months, 12 months
Proportion of patients with A1c <8%
Time Frame: 6 months, 12 months
The proportion of participants with A1c <8% (ADA target) will be calculated.
6 months, 12 months
Glycemic control based on A1c
Time Frame: 12 months
A1c reduction of > 1% with 20% non-inferiority margin
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of clinical visits for diabetes care
Time Frame: 12 months
The number of clinical visits (outpatient, inpatient and emergency department) for diabetes care will be calculated for each participant
12 months
Patient assessment of care burden
Time Frame: within 2 weeks of the physician visit or eConsult
Modified assessment of perceived research burden
within 2 weeks of the physician visit or eConsult
Provider assessment of acceptability
Time Frame: at baseline, 6 months, and completion of study period
Results from a 16 item post intervention questionnaire developed by the investigators will be used to assess provider acceptability. It includes 10 questions with a 5 item Likert scale from 1= Strongly disagree to 5= Strongly agree that asks about the usefulness, feasibility and how much they liked the eConsult and the physician visits. There are also 2 open-ended questions soliciting qualitative information about the intervention.
at baseline, 6 months, and completion of study period
Patient self efficacy and disease burden based on diabetes self management questionnaire and problem areas in diabetes short five-item short form questionnaire
Time Frame: at baseline and 6 months
Patient disease burden will be measured by the validated Problem Areas in Diabetes-5 question (PAID-5) survey. The five questions are from the original 20 item PAID survey (specifically questions 3, 6, 12, 16, and 19) and each has a 5-point Likert scale ranging from "not a problem" (score of 0) to "serious problem" (score of 4). The possible total scores of the PAID-5 ranges from 0 to 20, with higher scores implying greater emotional distress.
at baseline and 6 months
Efficacy of embedded clinical pharmacists
Time Frame: baseline, 3, 6, and 12 months
Changes in hemoglobin A1c will be used to assess the efficacy of the embedded clinical pharmacists
baseline, 3, 6, and 12 months
Cost effectiveness analysis (CEA)
Time Frame: 12 months
A Cost-Effectiveness Analysis will be done to compare the costs and health gains for the eConsult and standard of care interventions.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Devin Steenkamp, MD, Boston Medical Center, Endocrinology, Diabetes & Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-38363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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