Effects of a Remote Patient Monitoring Protocol on Glycemic Control in Adolescents With Type 1 Diabetes
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 13 - 18 |
| Updated: | 4/17/2018 |
| Start Date: | April 11, 2018 |
| End Date: | April 2020 |
| Contact: | Soumya Adhikari, MD |
| Email: | SOUMYA.ADHIKARI@childrens.com |
| Phone: | 214-456-5959 |
This study will use a randomized, crossover design. Children aged 13-18 years who have been
diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin A1c values
≥10.0% more than 60 days apart within the past year, with the most recent HbA1c value between
10-14%, will be placed into two separate treatment groups. Group A will undergo home
monitoring for 12 weeks through the use of the Vivify kit, which contains a wireless tablet
with daily medication/diet/symptom questionnaires. Group B will initially continue diabetes
management per standard of care, including quarterly office visits. After a period of 12
weeks, Group B will switch to the RPM protocol, while Group A will return to standard of
care. Both groups will have HbA1c values checked at the 0, 3, and 6 month time periods to
assess the effect of the remote monitoring protocol. Participation in the RPM protocol will
involve daily completion of the Care Plan questions, as well as weekly uploads of blood
glucose values using the Glooko, Inc (Mountain View, CA) application, and weekly video visits
with a member of the endocrinology team that will aim to address barriers to optimal care,
whether they be motivation, knowledge or other difficulties. Barriers to care will be
assessed in part through the completion of knowledge and self-efficacy assessments.
diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin A1c values
≥10.0% more than 60 days apart within the past year, with the most recent HbA1c value between
10-14%, will be placed into two separate treatment groups. Group A will undergo home
monitoring for 12 weeks through the use of the Vivify kit, which contains a wireless tablet
with daily medication/diet/symptom questionnaires. Group B will initially continue diabetes
management per standard of care, including quarterly office visits. After a period of 12
weeks, Group B will switch to the RPM protocol, while Group A will return to standard of
care. Both groups will have HbA1c values checked at the 0, 3, and 6 month time periods to
assess the effect of the remote monitoring protocol. Participation in the RPM protocol will
involve daily completion of the Care Plan questions, as well as weekly uploads of blood
glucose values using the Glooko, Inc (Mountain View, CA) application, and weekly video visits
with a member of the endocrinology team that will aim to address barriers to optimal care,
whether they be motivation, knowledge or other difficulties. Barriers to care will be
assessed in part through the completion of knowledge and self-efficacy assessments.
RPM Software The Remote Patient Monitoring application that will be used for this study was
created by Vivify Health. Vivify Health was founded in 2009, and their Remote Care Management
platform utilizes consumer electronics and wireless health devices that patients can use
easily from home. Using this platform, providers can create customized care plans for
patients, as well as provide education through multimedia and face-to-face interaction
through video conferences.
The Glooko mobile application allows patients to download diabetes data, including blood
sugar readings, directly from their meter to compatible iOS and Android devices. The data can
then be uploaded by the patient and viewed by providers.
Subjects Prospective study participants will be screened for by review of HbA1c values of
patients with upcoming Endocrine clinic appointments, or during diabetes-related hospital
admissions. Qualifying patients will be invited to participate in the study and written
consent will be obtained from their parents (and assent from patients 10 years of age and
older) prior to their randomization. Patients agreeing to participate in the study will be
randomly assigned using sealed, blinded envelopes to Group A or Group B. Each group will have
25 patients.
Pre-Study Measurements Both groups will have HbA1c measured at the pre-study clinic visit or
hospital admission as part of standard of care. After consenting to participation, each
subject will schedule a brief telephone check-in with an investigator within 1 week of the
initial encounter. Successful adherence to this telephone appointment will be used as a
barometer of ability to follow through on scheduled remote communications, and will be
required for randomization. After completing the telephone check-in, each patient will return
within 2 weeks of the initial encounter. At this visit, randomization will occur, and they
will complete 2 questionnaires at the beginning of the study: one knowledge assessment (the
Diabetes Knowledge Test 2 (DKT2)) [15] and one assessment of self-efficacy (the
Self-Management of Type 1 Diabetes in Adolescence (SMOD-A)) [16].
Intervention Groups Group A will be taught the remote monitoring expectations and will
receive training on how to use the Vivify RPM software at the same visit that randomization
occurs. Subjects in this group will be enrolled in the RPM protocol for the first 12 weeks of
their participation in the study. While on the RPM protocol, subjects will be required to
complete the Care Plan questions on a daily basis. They will also have scheduled video
conferences with study team physicians or advanced practice nurses on a weekly basis, and
will be expected to upload their blood glucose readings to Glooko each week for review. A
web-based provider dashboard will allow the study team to monitor patients' usage of the
software on a daily basis. Video visits are anticipated to last 15-20 minutes. During this
time the study team will review the data collected during the previous week, discuss ongoing
diabetes management and any barriers to care, and review selected diabetes self-management
educational topics with study participants. The Care Plan questions, Weekly Conference
questions, and Educational Objectives intended to be covered during the video visits are
appended to the end of this document. Patients in Group B will complete all pre-study
measurements at randomization, but remain on a quarterly visit schedule as per standard of
care for the first 12 weeks of their participation in the study.
After the first 12 weeks, patients in Group A will return to quarterly office visits with
their endocrinology team as per standard of care while patients in Group B enter into the RPM
protocol. Both groups will have a clinic visit with HbA1c checked, and will complete the DKT2
and SMOD-A questionnaires for the 2nd time.
The study will conclude with the 6 month visit for both groups. Both groups will have a HbA1c
checked, and will complete the post-study DKT2 and SMOD-A questionnaires for the 3rd and
final time.
created by Vivify Health. Vivify Health was founded in 2009, and their Remote Care Management
platform utilizes consumer electronics and wireless health devices that patients can use
easily from home. Using this platform, providers can create customized care plans for
patients, as well as provide education through multimedia and face-to-face interaction
through video conferences.
The Glooko mobile application allows patients to download diabetes data, including blood
sugar readings, directly from their meter to compatible iOS and Android devices. The data can
then be uploaded by the patient and viewed by providers.
Subjects Prospective study participants will be screened for by review of HbA1c values of
patients with upcoming Endocrine clinic appointments, or during diabetes-related hospital
admissions. Qualifying patients will be invited to participate in the study and written
consent will be obtained from their parents (and assent from patients 10 years of age and
older) prior to their randomization. Patients agreeing to participate in the study will be
randomly assigned using sealed, blinded envelopes to Group A or Group B. Each group will have
25 patients.
Pre-Study Measurements Both groups will have HbA1c measured at the pre-study clinic visit or
hospital admission as part of standard of care. After consenting to participation, each
subject will schedule a brief telephone check-in with an investigator within 1 week of the
initial encounter. Successful adherence to this telephone appointment will be used as a
barometer of ability to follow through on scheduled remote communications, and will be
required for randomization. After completing the telephone check-in, each patient will return
within 2 weeks of the initial encounter. At this visit, randomization will occur, and they
will complete 2 questionnaires at the beginning of the study: one knowledge assessment (the
Diabetes Knowledge Test 2 (DKT2)) [15] and one assessment of self-efficacy (the
Self-Management of Type 1 Diabetes in Adolescence (SMOD-A)) [16].
Intervention Groups Group A will be taught the remote monitoring expectations and will
receive training on how to use the Vivify RPM software at the same visit that randomization
occurs. Subjects in this group will be enrolled in the RPM protocol for the first 12 weeks of
their participation in the study. While on the RPM protocol, subjects will be required to
complete the Care Plan questions on a daily basis. They will also have scheduled video
conferences with study team physicians or advanced practice nurses on a weekly basis, and
will be expected to upload their blood glucose readings to Glooko each week for review. A
web-based provider dashboard will allow the study team to monitor patients' usage of the
software on a daily basis. Video visits are anticipated to last 15-20 minutes. During this
time the study team will review the data collected during the previous week, discuss ongoing
diabetes management and any barriers to care, and review selected diabetes self-management
educational topics with study participants. The Care Plan questions, Weekly Conference
questions, and Educational Objectives intended to be covered during the video visits are
appended to the end of this document. Patients in Group B will complete all pre-study
measurements at randomization, but remain on a quarterly visit schedule as per standard of
care for the first 12 weeks of their participation in the study.
After the first 12 weeks, patients in Group A will return to quarterly office visits with
their endocrinology team as per standard of care while patients in Group B enter into the RPM
protocol. Both groups will have a clinic visit with HbA1c checked, and will complete the DKT2
and SMOD-A questionnaires for the 2nd time.
The study will conclude with the 6 month visit for both groups. Both groups will have a HbA1c
checked, and will complete the post-study DKT2 and SMOD-A questionnaires for the 3rd and
final time.
Inclusion Criteria:
- Age 13-18 years old
- Diagnosed with Type 1 Diabetes Mellitus >1 year ago with at least one positive
diabetes autoantibody
- Patient on multiple daily injections of insulin, with no change to insulin type within
the past 3 months
- ≥2 separate HbA1c values (at least 60 days apart) ≥10.0% in the past year, with the
most recent HbA1c value ≥10.0%
- English-Speaking (patient and at least 1 parent)
- Patient or parents must own a smart phone or other device compatible with Glooko
Exclusion Criteria:
- Patients on Continuous Subcutaneous Insulin Infusion
- Diagnosed with Type 2 Diabetes or taking metformin
- Other chronic medical condition that would be likely to affect blood glucose.
Exceptions include:
- Hypothyroidism on treatment with normal thyroid function tests
- Asthma with no oral steroids within past 3 months
- Unstable social situation that could compromise diabetes management or study follow-up
in the judgment of the investigators
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