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Device

Continuous Glucose Monitoring for Type 1 Diabetes

N/A
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female participants must have a negative pregnancy test
Poorly controlled T1D as evidenced by a >40% annual risk of developing DKA in the following year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will test whether or not real-time remote continuous glucose monitoring can improve glycemic control in adolescents with Type 1 Diabetes.

Who is the study for?
This trial is for adolescents aged 13-18 with Type 1 Diabetes, poorly controlled blood sugar, and a high risk of diabetic ketoacidosis. They must be willing to wear a CGM device, share glucose data with the team, and engage in secure texting. It's open to all ethnicities and both sexes if they're not pregnant or planning pregnancy, have no severe chronic diseases affecting blood sugar control or allergies to CGM adhesives.Check my eligibility
What is being tested?
The study tests whether remote continuous glucose monitoring (CGM) helps manage Type 1 Diabetes in teens. Participants will first use a blinded CGM then switch to a non-blinded one while the team monitors their glucose levels in real-time for three months via smartphone apps.See study design
What are the potential side effects?
While this study does not involve medication that typically has side effects, wearing a CGM may cause skin irritation or discomfort at the site of attachment. The psychological impact of constant monitoring is also considered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
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I am not pregnant.
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I have a high risk of diabetic ketoacidosis due to my Type 1 Diabetes.
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I have been diagnosed with type 1 diabetes for over six months.
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My gender or ethnicity does not exclude me from this trial.
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I have been diagnosed with type 1 diabetes for over six months.
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I am willing to wear a continuous glucose monitor (CGM) and share the data.
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I am between 13 and 18 years old.
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I use insulin injections or an insulin pump for my diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in hemoglobin A1c after three-month follow-up visit after remote continuous glucose monitoring monitoring and secure text messaging.
Other outcome measures
Average time spent by medical provider per participant per day.
CGM percent hyperglycemia will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
CGM time in range percentage will be compared between baseline, clinical remote monitoring, and self-monitoring of CGM
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Who is running the clinical trial?

DexCom, Inc.Industry Sponsor
135 Previous Clinical Trials
29,787 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,043 Previous Clinical Trials
1,053,530 Total Patients Enrolled

Media Library

CGM (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04540536 β€” N/A
Type 1 Diabetes Research Study Groups:
Type 1 Diabetes Clinical Trial 2023: CGM Highlights & Side Effects. Trial Name: NCT04540536 β€” N/A
CGM (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04540536 β€” N/A
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT04540536 β€” N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of this trial in terms of participant recruitment?

"Affirmative. Clinicaltrials.gov hosts data that indicates this investigation is actively seeking participants, which was initially posted on November 1st 2021 and recently revised on September 26th 2022. This trial requires 20 subjects to be recruited from a single location."

Answered by AI

May I participate in this clinical trial?

"The qualifications for this medical trial are those with diabetes and an autoimmune disorder, aged between 13 and 18 years old. As of now, the study is recruiting approximately 20 individuals."

Answered by AI

Are any further participants being accepted for this research trial?

"Affirmative. The clinical trial is still taking participants - information on the website states that it was initially posted on November 1st 2021 and most recently refreshed on September 26th 2022; 20 people are needed to be enrolled from one medical centre."

Answered by AI

Is the demographic of this trial limited to individuals who have surpassed the age of 70?

"As indicated by the protocol, the age range for enrollment in this clinical trial is 13 to 18 years."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I am on a dexcom and I was Anna see the difference.
PatientReceived 1 prior treatment
~1 spots leftby Jun 2024