DiabetesNCT04089202
Diabetes eConsult Non-Inferiority Study
A study testing eConsult in people with Diabetes, run by Boston Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- eConsult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 27 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes
- Being tested
- eConsult, Standard of care
- Keywords
- Diabetes specialty care, Flash glucose monitoring, Clinical pharmacists, eConsults, Freestyle Libre sensor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eConsultOther
Completion of electronic consult utilizing data collected from flash glucose monitoring
Standard of careOther
Care by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: eConsult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (A1c) at baseline
A1c will be obtained as standard of care and values documented in the medical record.
Measured: baseline
Hemoglobin A1c (A1c) at 3 months
A1c will be obtained as standard of care and values documented in the medical record.
Measured: 3 months
Hemoglobin A1c (A1c) at 6 months
A1c will be obtained as standard of care and values documented in the medical record.
Measured: 6 months
Hemoglobin A1c (A1c) at 12 months
A1c will be obtained as standard of care and values documented in the medical record.
Measured: 12 months
Percentage change in A1c to 6 months
The percent change in A1c will be calculated from baseline to six months
Measured: baseline, 6 months
Percentage change in A1c to 12 months
The percent change in A1c will be calculated from baseline to 12 months
Measured: baseline, 12 months
Proportion of patients with A1c <7%
The proportion of participants with A1c <7% (ADA target) will be calculated.
Measured: 6 months, 12 months
Proportion of patients with A1c <8%
The proportion of participants with A1c <8% (ADA target) will be calculated.
Measured: 6 months, 12 months
Glycemic control based on A1c
A1c reduction of > 1% with 20% non-inferiority margin
Measured: 12 months
Secondary outcomes (6)
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
Measured: 12 months
Patient assessment of care burden
Modified assessment of perceived research burden
Measured: within 2 weeks of the physician visit or eConsult
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.
Measured: 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
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.
Measured: at baseline and 6 months
Efficacy of embedded clinical pharmacists
Changes in hemoglobin A1c will be used to assess the efficacy of the embedded clinical pharmacists
Measured: baseline, 3, 6, and 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start3 Feb 2020
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
Why it stopped: Unable to enroll additional participants and funding ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devin Steenkamp, MD, Principal investigator, Boston Medical Center, Endocrinology, Diabetes & Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089202
- Sponsor's protocol ID
- H-38363
- Status last verified
- Feb 2023
- First submitted
- 11 Sep 2019
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Electronic Versus In-Person Access to Specialty Diabetes Expertise
- ClinicalTrials.gov ID
- NCT04089202
- Acronym / sponsor ID
- H-38363
- Conditions
- Diabetes
- Keywords
- Diabetes specialty care, Flash glucose monitoring, Clinical pharmacists, eConsults, Freestyle Libre sensor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll additional participants and funding ended.
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person visit arm | Active comparator | Other: Standard of careIn 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. |
| Freestyle Libre sensor arm | Experimental | Other: eConsultIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eConsultCompletion of electronic consult utilizing data collected from flash glucose monitoring | Other | Freestyle Libre sensor arm |
| Standard of careCare by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences. | Other | In-person visit arm |
Primary outcome
Hemoglobin A1c (A1c) at baseline
Time frame: baseline
A1c will be obtained as standard of care and values documented in the medical record.
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.
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.
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.
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
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
Proportion of patients with A1c <7%
Time frame: 6 months, 12 months
The proportion of participants with A1c <7% (ADA target) will be calculated.
Proportion of patients with A1c <8%
Time frame: 6 months, 12 months
The proportion of participants with A1c <8% (ADA target) will be calculated.
Glycemic control based on A1c
Time frame: 12 months
A1c reduction of > 1% with 20% non-inferiority margin
6 secondary outcomes
Number of clinical visits for diabetes care
Time frame: 12 months
Patient assessment of care burden
Time frame: within 2 weeks of the physician visit or eConsult
Provider assessment of acceptability
Time frame: 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
Efficacy of embedded clinical pharmacists
Time frame: baseline, 3, 6, and 12 months
Cost effectiveness analysis (CEA)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Unable to enroll additional participants and funding ended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devin Steenkamp, MD principal investigator
Boston Medical Center, Endocrinology, Diabetes & Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eConsult in people with Diabetes, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to enroll additional participants and funding ended.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (A1c) at baseline (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.