Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1, Noncompliance, Patient

Intervention / Treatment
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* Other: Continuous Glucose Monitoring
* Other: Secure texting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Continuous Glucose Monitoring|Participants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.|
|Other: Secure texting|A secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c after three-month follow-up visit after remote continuous glucose monitoring monitoring and secure text messaging. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Continuous Glucose Monitors, Telemedicine, Remote Monitoring, Secure Texting, Poorly controlled diabetes