- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540536
Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
September 15, 2023 updated by: Abha Choudhary, University of Texas Southwestern Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern Medical Center
-
Contact:
- Abha Choudhary, MD
- Phone Number: 214-456-5959
- Email: abha.choudhary@utsouthwestern.edu
-
Contact:
- Pooja Choudhari, MD
- Phone Number: 2144565959
- Email: pooja.choudhari@utsouthwestern.edu
-
Sub-Investigator:
- Perrin White, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in hemoglobin A1c after three-month follow-up visit after remote continuous glucose monitoring monitoring and secure text messaging.
Time Frame: 3 months
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depression score after clinical remote CGM monitoring and secure text messaging.
Time Frame: 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.
|
3 months
|
Change in quality of life score after clinical remote CGM monitoring and secure text messaging.
Time Frame: 3 months
|
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.
|
3 months
|
Change in self efficacy score after clinical remote CGM monitoring and secure text messaging.
Time Frame: 3 months
|
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.
|
3 months
|
Change in parent-child collaboration score after clinical remote CGM monitoring and secure text messaging.
Time Frame: 3 months
|
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.
|
3 months
|
Change in depression score 3 months after clinical remote continuous glucose monitoring monitoring and immediately after a period of self-monitoring of CGM data
Time Frame: 6 months
|
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.
|
6 months
|
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
Time Frame: 6 months
|
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.
|
6 months
|
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
Time Frame: 6 months
|
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.
|
6 months
|
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
Time Frame: 6 months
|
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.
|
6 months
|
The percent difference in Hemoglobin A1c after clinical remote monitoring and after self-monitoring of the CGM
Time Frame: 6 months
|
6 months
|
|
CGM time in range percentage will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
Time Frame: 6 months
|
6 months
|
|
CGM percent hyperglycemia will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
Time Frame: 6 months
|
6 months
|
|
Mean CGM glucose (in mg/dL) will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
Time Frame: 6 months
|
6 months
|
|
Percent CGM wear will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
Time Frame: 6 months
|
6 months
|
|
Mean time (in minutes) taken for a text to be read by a participant or a guardian.
Time Frame: 3 months
|
3 months
|
|
Average time spent by medical provider per participant per day.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
July 17, 2020
First Submitted That Met QC Criteria
August 31, 2020
First Posted (Actual)
September 7, 2020
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 15, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU-2020-0699
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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