Clinical trial NCT04540536: Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents with Poorly Controlled Type 1 Diabetes
Official title: Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents with Poorly Controlled Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Noncompliance, Patient
Keywords: Type 1 Diabetes
Continuous Glucose Monitors
Telemedicine
Remote Monitoring
Secure Texting
Poorly controlled diabetes
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2020-09-07
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adolescents with Type 1 Diabetes (age 13-18 years, T1D duration \>6 months managed on insulin) and poor glycemic control will wear a blinded CGM to obtain baseline data. After assuring adherence to CGM wear, participants will receive a non-blinded CGM and will share their blood glucose levels with the study team. Clinical personnel will remotely monitor patients in real-time for 3 months and communicate regularly over secure text messaging with participants and their parents. Following active remote monitoring, the participants will wear a non-blinded CGM for 3 months. Primary outcome assessment will be the change in HbA1c after 3 months of real-time remote continuous glucose monitoring.


Eligibility criteria: Inclusion Criteria:

* Age between 13-18
* Diagnosis of type 1 diabetes for at least six months.
* Both sexes and all ethnicities included.
* Subject and at least one parent able to communicate in English.
* Poorly controlled T1D as evidenced by a \>40% annual risk of developing DKA in the following year
* Treated with subcutaneous insulin, either with a basal/bolus insulin regimen or a continuous subcutaneous insulin infusion (CSII) device.
* Willing to wear CGM and utilize the share function to clinician and guardian, with measuring blood glucose checks as required by the CGM.
* Owning a smartphone compatible with Dexcom G6 software to allow the use of share/follow features with internet access capabilities
* Willing to participate in secure text messaging with study personnel.
* Female participants must have a negative pregnancy test.

Exclusion Criteria:

* Type 2 diabetes, secondary diabetes or CF related diabetes.
* Other severe chronic disease (e.g., cancer) which in the judgment of the investigator is likely to significantly affect glycemic control.
* Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but we will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
* Patients with hypothyroidism or hyperthyroidism must be clinically euthyroid and have free T4 and TSH within age-appropriate reference ranges at last medically indicated testing. Patients with out of range values may be retested after medication dose adjustment.
* Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with study activities. Severe uncontrolled depression defined as PHQ-9A \>9 at time of enrollment is an exclusion criterion.
* Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with study activities.
* Regular CGM for the month preceding study period.
* Pregnancy, planned pregnancy or breast feeding
* CGM adhesive allergy
* Skin condition that makes CGM placement contraindicated.
* Sickle cell disease or hemoglobinopathy
* Red blood cell transfusion within 3 months prior to study enrollment

Primary outcomes:
measure: Change in hemoglobin A1c after three-month follow-up visit after remote continuous glucose monitoring monitoring and secure text messaging.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Change in depression score after clinical remote CGM monitoring and secure text messaging.
timeFrame: 3 months
measure: Change in quality of life score after clinical remote CGM monitoring and secure text messaging.
timeFrame: 3 months
measure: Change in self efficacy score after clinical remote CGM monitoring and secure text messaging.
timeFrame: 3 months
measure: Change in parent-child collaboration score after clinical remote CGM monitoring and secure text messaging.
timeFrame: 3 months
measure: Change in depression score 3 months after clinical remote continuous glucose monitoring monitoring and immediately after a period of self-monitoring of CGM data
timeFrame: 6 months
measure: Change in quality of life score 3 months after clinical remote continuous glucose monitoring monitoring and immediately after a period of self-monitoring of CGM data
timeFrame: 6 months
measure: Change in self efficacy score 3 months after clinical remote continuous glucose monitoring monitoring and immediately after a period of self-monitoring of CGM data
timeFrame: 6 months
measure: Change in parent-child collaboration score 3 months after clinical remote continuous glucose monitoring monitoring and immediately after a period of self-monitoring of CGM data
timeFrame: 6 months
measure: The percent difference in Hemoglobin A1c after clinical remote monitoring and after self-monitoring of the CGM
timeFrame: 6 months
measure: CGM time in range percentage will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
timeFrame: 6 months
measure: CGM percent hyperglycemia will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
timeFrame: 6 months
measure: Mean CGM glucose (in mg/dL) will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
timeFrame: 6 months
measure: Percent CGM wear will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
timeFrame: 6 months
measure: Mean time (in minutes) taken for a text to be read by a participant or a guardian.
timeFrame: 3 months
measure: Average time spent by medical provider per participant per day.
timeFrame: 3 months
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References: