Diabetes eConsult Non-Inferiority Study

NCT04089202 | Terminated DMC

• 1 other identifier: H-38363
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes

Keywords

Diabetes specialty care; Flash glucose monitoring; Clinical pharmacists; eConsults; Freestyle Libre sensor

Outcome Measures

Primary Outcomes (9)

• Hemoglobin A1c (A1c) at baseline

  A1c will be obtained as standard of care and values documented in the medical record.

  baseline

• Hemoglobin A1c (A1c) at 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

  A1c will be obtained as standard of care and values documented in the medical record.

  6 months

• Hemoglobin A1c (A1c) at 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

  The percent change in A1c will be calculated from baseline to six months

  baseline, 6 months

• Percentage change in A1c to 12 months

  The percent change in A1c will be calculated from baseline to 12 months

  baseline, 12 months

• Proportion of patients with A1c <7%

  The proportion of participants with A1c \<7% (ADA target) will be calculated.

  6 months, 12 months

• Proportion of patients with A1c <8%

  The proportion of participants with A1c \<8% (ADA target) will be calculated.

  6 months, 12 months

• Glycemic control based on A1c

  A1c reduction of \> 1% with 20% non-inferiority margin

  12 months

Secondary Outcomes (6)

• Number of clinical visits for diabetes care

  12 months

• Patient assessment of care burden

  within 2 weeks of the physician visit or eConsult

• Provider assessment of acceptability

  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

  at baseline and 6 months

• Efficacy of embedded clinical pharmacists

  baseline, 3, 6, and 12 months

Study Arms (2)

In-person visit arm

ACTIVE COMPARATOR

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

Freestyle Libre sensor arm

EXPERIMENTAL

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

Interventions

eConsult OTHER

Completion of electronic consult utilizing data collected from flash glucose monitoring

Freestyle Libre sensor arm

Standard of care OTHER

Care by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences.

In-person visit arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Devin Steenkamp, MD

  Boston Medical Center, Endocrinology, Diabetes & Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: February 3, 2020
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)