Diabetes eConsult Non-Inferiority Study

Diabetes Clinical Trial

Official title:

Comparing Electronic Versus In-Person Access to Specialty Diabetes Expertise

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04089202
• Other study ID #: H-38363
• Status: Terminated
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: September 27, 2022

Study information

• Verified date: February 2023
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: September 27, 2022
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• eConsult
Completion of electronic consult utilizing data collected from flash glucose monitoring
• Standard of care
Care by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (A1c) at baseline	A1c will be obtained as standard of care and values documented in the medical record.	baseline
Primary	Hemoglobin A1c (A1c) at 3 months	A1c will be obtained as standard of care and values documented in the medical record.	3 months
Primary	Hemoglobin A1c (A1c) at 6 months	A1c will be obtained as standard of care and values documented in the medical record.	6 months
Primary	Hemoglobin A1c (A1c) at 12 months	A1c will be obtained as standard of care and values documented in the medical record.	12 months
Primary	Percentage change in A1c to 6 months	The percent change in A1c will be calculated from baseline to six months	baseline, 6 months
Primary	Percentage change in A1c to 12 months	The percent change in A1c will be calculated from baseline to 12 months	baseline, 12 months
Primary	Proportion of patients with A1c <7%	The proportion of participants with A1c <7% (ADA target) will be calculated.	6 months, 12 months
Primary	Proportion of patients with A1c <8%	The proportion of participants with A1c <8% (ADA target) will be calculated.	6 months, 12 months
Primary	Glycemic control based on A1c	A1c reduction of > 1% with 20% non-inferiority margin	12 months
Secondary	Number of clinical visits for diabetes care	The number of clinical visits (outpatient, inpatient and emergency department) for diabetes care will be calculated for each participant	12 months
Secondary	Patient assessment of care burden	Modified assessment of perceived research burden	within 2 weeks of the physician visit or eConsult
Secondary	Provider assessment of acceptability	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
Secondary	Patient self efficacy and disease burden based on diabetes self management questionnaire and problem areas in diabetes short five-item short form questionnaire	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
Secondary	Efficacy of embedded clinical pharmacists	Changes in hemoglobin A1c will be used to assess the efficacy of the embedded clinical pharmacists	baseline, 3, 6, and 12 months
Secondary	Cost effectiveness analysis (CEA)	A Cost-Effectiveness Analysis will be done to compare the costs and health gains for the eConsult and standard of care interventions.	12 months