Diabetes Mellitus, Type 1, Noncompliance, Patient
Conditions
Keywords
Type 1 Diabetes, Continuous Glucose Monitors, Telemedicine, Remote Monitoring, Secure Texting, Poorly controlled diabetes
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.
Interventions
OTHERContinuous Glucose Monitoring
Participants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.
OTHERSecure texting
A secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel
Sponsors
University of Texas Southwestern Medical Center
DexCom, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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 \>30% annual risk of developing DKA in the following year OR Hemoglobin A1c ≥ 12% * 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 uncontrolled hypothyroidism (TSH \>20) or uncontrolled hyperthyroidism will be excluded from the study. 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 \>15 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c From Baseline to 3 Months | 3 months | Change in hemoglobin A1c from baseline to 3 months (three-month follow-up visit after remote continuous glucose monitoring and secure text messaging) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Score After Clinical Remote CGM Monitoring and Secure Text Messaging. | 3 months | Depression screening will be assessed by Patient Health Questionnaire (PHQ-9A), a depression questionnaire consisting of 9 items answered on a scale from "0" (not at all) to "3" (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. |
Countries
United States
Participant flow
Pre-assignment details
Subjects with Type 1 Diabetes were enrolled in the study
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 14.5 years STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HbA1C | 12 percent STANDARD_DEVIATION 1.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 11 |
| other Total, other adverse events | 2 / 11 |
| serious Total, serious adverse events | 1 / 11 |
Outcome results
None listed