Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05161793 |
| Other study ID # |
TELE-MONITOR DM |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
May 31, 2025 |
Study information
| Verified date |
November 2023 |
| Source |
University of Southern California |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this single center observational study is to determine the effect of
continuous remote continuous glucose monitor (CGM) reporting coupled with a telemedicine
intervention (Tele-CGM program) on levels of HbA1C in adults with poorly controlled type 1 or
type 2 diabetes. The investigators will follow 200 English and Spanish speaking adults (125
type 2 and 75 type 1 patients) who have an HbA1C >8% over 12 months. The primary analysis
will follow the intention-to-treat principle; participants will all be offered the
intervention. The primary trial outcome of HbA1c/Glucose Management Indicator (GMI) at 6 and
12 months will be compared from baseline using a linear regression model. The primary
independent variable will be the HbA1C from baseline to 6 and 12 months. Patients will serve
as their own control. Results will be summarized as group-specific mean, standard deviation
(SD) HbA1c, along with a mean treatment difference and 95% confidence interval. Model
assumptions including normality and homoscedasticity of residuals will be evaluated;
normalizing transformations or rank-based non-parametric procedures will be used as needed.
The complete evaluation of HbA1c, including baseline, 6-month and 12 month measurements will
be analyzed with mixed effects linear regression, specifying a random participant-level
intercept and an unstructured covariance matrix, to accommodate the repeatedly measured data.
The secondary trial outcomes of time in range (TIR; CGM glucose levels 70-180) and
questionnaires will be compared from baseline to 6 and 12 months using linear regression
procedures as detailed above.
Description:
SUMMARY OF STUDY RATIONAL - Our project focuses on two populations; those with type 1
diabetes (T1D) and those with poorly controlled type 2 diabetes (T2D). Telemedicine
Monitoring of Adults with Uncontrolled Diabetes Mellitus (Tele-MONITOR DM) is designed to
reduce health care disparities in under resourced populations by enhancing existing
telehealth visits for individuals with poorly controlled diabetes through continuous glucose
monitoring (CGM) with data automatically transmitted to a clinic dashboard to allow for
outreach to patients as needed in between routinely scheduled visits and feedback to primary
care providers for medication management.
Few people with diabetes reach their treatment targets. This is particularly true for the
under resourced who lack access to medical care who often have very high glucose levels, as
well as have a risk for hypoglycemia. For our patients, part of the difficulty in accessing
care is the disruption it creates in their schedule to take the time to come in for an office
visit. The use of telemedicine due to the COVID pandemic has expanded our ability to reach
patients in a convenient manner, based on the patient's preferences rather than a fixed
clinic schedule. Use of technology has increased along with this, particularly because
Medicare rules for covering technology have expanded. This allows for close monitoring and
frequent medication dose adjustment to treat both hyper- and hypo-glycemia. These lessons
learned during COVID create a new opportunity to expand the use of technology to underserved
areas where uptake has been lagging but where the need is greatest.
Our system of monitoring, which the investigators originally called Tele-CGM will send alerts
to our clinic that will allow for outreach to patients who need assistance, rather than
waiting for them to contact the clinic. By looking both at the daily alerts as well as weekly
data updates on each patient, the investigators should help keep patients safer, start and
uptitrate guideline-recommended medications more effectively and work to encourage adherence
to lifestyle and medications. Originally, the investigators had hoped to develop our Tele-CGM
system to include data from all CGM systems. Unfortunately this is not currently possible.
Therefore the investigators plan to work the Freestyle Libre 2. The data will be monitored
through the existing LibreView system, with enhanced functionality for population management.
The CGM system selected for each patient will be individualized based on the patient's
preferences, clinical need for the device and insurance coverage (if available). For those
without a CGM, they will be provided with a Freestyle Libre device free of charge.
If our findings prove the utility of our system, it will validate the role of treatment
intensification for diabetes management in primary care, using asynchronous data collection
from CGM devices by diabetes educators supervised by an endocrinologist. It will also assess
the utility of a device-dashboard that will provide near real-time alerts to clinic staff so
that they can respond to unusually high and low blood glucose values as well as
discontinuation of sensor use.
INTERVENTION Baseline Visit-Visit 1 1. Obtain informed consent 2. Obtain clinical data on
patient including diabetes and medical history 3. Administer questionnaires 4. Measure point
of care HbA1C 5. Start blinded CGM device (even if using their own CGM) Baseline Blinded CGM
wear - Visit 2
1. Downloaded from the patient's blinded CGM device.
2. Teach the patient how the remote monitoring systems works.
3. The patient will be signed into the LibreView portal using a research code name and
email.
4. Systems will be checked to be sure they are functioning
5. Remote monitoring program will be activated.
6. Telemedicine procedure will be discussed with patient; emergency contact numbers will be
obtained in case patient cannot be reached.
7. Telemonitoring will commence (see below)
8. Recommendations will be given to the patient and his/her provider for medication
adjustment/intensification following the Los Angeles County Department of Health
Services Protocols for Diabetes Management.
9. Patient will be given basic education information and a link to Los Angeles County +
University of Southern California patient educational videos. They will be able to watch
these videos at home or in clinic.
Month 6 - Blinded CGM Visit 3
1. Provided blinded CGM device (in-person or by mail) three weeks prior to Visit 2
2. Instruct subjects to monitor their glucose levels with the their usual method (CGM or
BGM) during the blinded CGM period.
6 Month Visit - Visit 4
1. Administer questionnaires
2. Measure point of care HbA1C
3. Collect blinded CGM data
4. Review and document medication use, hospitalizations/emergency department/outpatient
(in-person or telemedicine) visits Month 12 - Blinded CGM
1. Provided blinded CGM device (in-person or by mail) three weeks prior to Visit 2 2.
Instruct subjects to monitor their glucose levels with the their usual method (CGM or BGM)
during the blinded CGM period.
12 Month Visit - Visit 6
1. Administer questionnaires
2. Measure point of care HbA1C
3. Collect blinded CGM data
4. Review and document medication use, hospitalizations/emergency department/outpatient
(in-person or telemedicine) visits DATA COLLECTION AND TESTING PROCEDURES (Baseline, 6
months and 12 months) HbA1c - HbA1c will be obtained using the point of care Siemens DCA
Vantage Analyzer.
Continuous Glucose Monitoring (CGM) Blinded Mode - A commercially available Libre Pro (for
blinded mode) CGM device will be provided and a sensor will be inserted.
Data from TeleMonitor Program (using FDA approved LibreView), including frequency and types
of alerts, action taken. A commercially available Libre 2 CGM device will be provided and a
sensor will be inserted. The participant will receive instructions on calibration,
insertions, maintenance, use, and removal of the sensor. The Libre 2 CGM is linked to the
LibreView program which captures CGM data and initiates alerts based on the following
parameters:
1. ≥4 hours without CGM signal
2. ≥2 hours 54 - 70 mg/dl
3. 15 minutes <54 mg/dl Brief Patient Health Questionnaire (PHQ-8) - The PHQ-8 is an
eight-item scale developed specifically to screen for depression. Each question has a
choice format of the number of days in the past two weeks the question apply to them
(Not at all 0-1day, Several days 2-6 days, More than half the days 7- 11 days, and
Nearly every day 12-14 days). Administration time is approximately 10 minutes.
Diabetes Treatment Satisfaction Questionnaire (DTSQ) - The DTSQ assess patient satisfaction
with diabetes treatment each. It is composed of eight questions, each of which is scored by
patients on a scale ranging from zero (e.g., "very dissatisfied", "very inconvenient") to six
(e.g., "very satisfied", "very convenient"). The questionnaire is composed of two different
factors. The first factor assesses treatment satisfaction and consists of six questions (Q 1,
4, 5, 6, 7 and 8). These six questions ask about "satisfaction with current treatment",
"flexibility", "convenience", "understanding of diabetes", "recommend treatment to others"
and "willingness to continue", respectively. The second factor consists of two questions (Q 2
and 3), which assess the burden from hyper- and hypoglycemia, respectively (zero being "none
of the time" to six being "most of the time"). Treatment satisfaction is assessed as the sum
of the scores of the six questions on the first factor (total score 36), with a higher score
indicating higher treatment satisfaction. Administration time is approximately 10 minutes.
Glucose Monitoring Satisfaction Survey (GMSS) - The GMSS assess treatment satisfaction with
glucose monitoring devices and its impact on quality of life and other patient-reported
outcomes for patients with type 1 and type 2 diabetes. It is a 15 item scale asking subjects
how much they agree or disagree (Likert scale 1-5) with each statement as it pertains to
their current glucose monitor. There are 4 sub-scales Openness, Emotional burden, Behavioral
burden, and Trust (for type 1) Worthwhileness (for type 2). Higher scores indicate higher
satisfaction. Administration time is approximately 10 minutes.
Diabetes Distress Scale for T1D (DDS T1D) - The DDS T1D is a 28-item self-report scale that
highlights seven critical dimensions of distress: powerlessness, management distress,
hypoglycemia distress, negative social perceptions, eating distress, physician distress, and
friends/family distress. The seven sub-scales include:
Powerlessness: A broad sense of feeling discouraged about diabetes; e.g., "feeling that no
matter how hard I try with my diabetes, it will never be |good enough." Management Distress:
Disappointment with the patient's self-care efforts; e.g., "feeling that I don't give my
diabetes as much attention as I probably should." Hypoglycemia Distress: Concerns about
hypoglycemic events; e.g., "feeling that I can't ever be safe from the possibility of a
serious hypoglycemic event." Negative Social Perception Distress: Concerns about the possible
negative judgments of others; e.g., "feeling like I have to hide my diabetes from other
people.
Eating Distress: Concerns that the patient's eating is out of control; e.g., "feeling that
thoughts about food and eating control my life." Physician Distress: Disappointment with the
patient's current health care professionals; e.g., "feeling that I don't get help I really
need from my diabetes doctor about managing diabetes." Friend/Family Distress: A perception
that there is too much focus on diabetes amongst the patient's loved ones; e.g., "feeling
that my family and friends make a bigger deal out of diabetes than they should." Higher
scores indicate higher stress. Administration time is approximately 15 minutes.
Diabetes Distress Scale for T2D (DDS T2D) - The DDS T2D is a 17 item self-report scale that
reflects overall diabetes distress from all sources with four sub-scales:
Emotional Burden (5 items): feeling overwhelmed, frightened or fearful about managing the
demands of diabetes over time.
Regimen Distress (5 items): feeling that they are failing by not managing their diabetes
well, e.g., meal plan, exercise, etc.
Interpersonal Distress (3 items): feeling that they are not receiving sufficient support for
their diabetes among family and friends.
Physician Distress (4 items): worries about health care and obtaining sufficient expertise,
support and direction from health care providers.
Each question is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant
problem." Higher scores indicate higher stress. Administration time is approximately 10
minutes.
Assessment of Sever Hypoglycemia and Diabetic Ketoacidosis -The Assessment of Severe
Hypoglycemia and Diabetic Ketoacidosis is an interviewer administered survey assessing if the
subject had any episodes of severe hypoglycemia and/or diabetic ketoacidosis since their last
study visit. Events are recorded to assess frequency, as is type of assistance required to
treat the event. Administration time is approximately 5 minutes.
