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

Primary Purpose

Diabetes Mellitus, Type 1, Noncompliance, Patient

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitoring
Secure texting
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 Diabetes, Continuous Glucose Monitors, Telemedicine, Remote Monitoring, Secure Texting, Poorly controlled diabetes

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Southwestern Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Change in hemoglobin A1c after three-month follow-up visit after remote continuous glucose monitoring monitoring and secure text messaging.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2020
Last Updated
September 15, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04540536
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
DexCom, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Noncompliance, Patient
Keywords
Type 1 Diabetes, Continuous Glucose Monitors, Telemedicine, Remote Monitoring, Secure Texting, Poorly controlled diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Continuous Glucose Monitoring
Intervention Description
Participants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.
Intervention Type
Other
Intervention Name(s)
Secure texting
Intervention Description
A secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel
Primary Outcome Measure Information:
Title
Change in hemoglobin A1c after three-month follow-up visit after remote continuous glucose monitoring monitoring and secure text messaging.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Change in depression score after clinical remote CGM monitoring and secure text messaging.
Description
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.
Time Frame
3 months
Title
Change in quality of life score after clinical remote CGM monitoring and secure text messaging.
Description
Quality of life screening assessed by the Pediatric Quality Life Inventory for teens 13-18, PedsQL4.08, a 23-item questionnaire with a 5-point Likert scale from 0 (never) to 4 (almost always). Items are reversed and then added. The higher the score, the better the quality of life.
Time Frame
3 months
Title
Change in self efficacy score after clinical remote CGM monitoring and secure text messaging.
Description
Self-efficacy assessed by The Self-Efficacy for Diabetes Self-Management Measure (SEDM), a 10-item self-report scale that covers the major aspects of diabetes self-management including monitoring blood glucose levels, dosing insulin, food choices, and exercise, and performance of diabetes-related tasks when feeling overwhelmed or frustrated. Total score range for the SEDM is 1-10, with a higher score indicating higher self-efficacy.
Time Frame
3 months
Title
Change in parent-child collaboration score after clinical remote CGM monitoring and secure text messaging.
Description
Parent-child collaboration in diabetes care assessed using the Collaborative Parent Involvement Scale, a 12-item questionnaire with a five-point Likert scale, from almost never to always, and is targeted for adolescents. The scale aims to assess parental use of problem solving, teachable moments, diabetes, help with autonomy, and supervision of diabetes care when the adolescent is not around. Higher scores indicate better parent-adolescent collaboration.
Time Frame
3 months
Title
Change in depression score 3 months after clinical remote continuous glucose monitoring monitoring and immediately after a period of self-monitoring of CGM data
Description
Depression screening 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.
Time Frame
6 months
Title
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
Description
Quality of life screening assessed by the Pediatric Quality Life Inventory for teens 13-18, PedsQL4.08, a 23-item questionnaire with a 5-point Likert scale from 0 (never) to 4 (almost always). Items are reversed and then added. The higher the score, the better the quality of life.
Time Frame
6 months
Title
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
Description
Self-efficacy assessed by The Self-Efficacy for Diabetes Self-Management Measure (SEDM), a 10-item self-report scale that covers the major aspects of diabetes self-management including monitoring blood glucose levels, dosing insulin, food choices, and exercise, and performance of diabetes-related tasks when feeling overwhelmed or frustrated. Total score range for the SEDM is 1-10, with a higher score indicating higher self-efficacy.
Time Frame
6 months
Title
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
Description
Parent-child collaboration in diabetes care assessed using the Collaborative Parent Involvement Scale, a 12-item questionnaire with a five-point Likert scale, from almost never to always, and is targeted for adolescents. The scale aims to assess parental use of problem solving, teachable moments, diabetes, help with autonomy, and supervision of diabetes care when the adolescent is not around. Higher scores indicate better parent-adolescent collaboration.
Time Frame
6 months
Title
The percent difference in Hemoglobin A1c after clinical remote monitoring and after self-monitoring of the CGM
Time Frame
6 months
Title
CGM time in range percentage will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
Time Frame
6 months
Title
CGM percent hyperglycemia will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
Time Frame
6 months
Title
Mean CGM glucose (in mg/dL) will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
Time Frame
6 months
Title
Percent CGM wear will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
Time Frame
6 months
Title
Mean time (in minutes) taken for a text to be read by a participant or a guardian.
Time Frame
3 months
Title
Average time spent by medical provider per participant per day.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abha Choudhary, MD
Phone
214-456-5959
Email
abha.choudhary@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Pooja Choudhari, MD
Phone
2144565959
Email
pooja.choudhari@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Perrin White, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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