Diabetes Mellitus, Type 1NCT04540536

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

A study testing Continuous Glucose Monitoring and Secure texting in people with Diabetes Mellitus, Type 1 and Noncompliance, Patient, run by University of Texas Southwestern Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 13 to 18 years
Conditions the study is for: Diabetes Mellitus, Type 1, Noncompliance, Patient
What is being tested?: Continuous Glucose Monitoring and Secure texting
How many people: 20 participants
Where: 2 sitesUnited States
Study dates: 1 Nov 2021to 1 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Show all 10Show fewer

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.

Who cannot join

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.

Show all 11Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Childrens Medical Center
Dallas, Texas, 75390
UT Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

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.

Conditions: Diabetes Mellitus, Type 1, Noncompliance, Patient
Being tested: Continuous Glucose Monitoring, Secure texting
Keywords: Type 1 Diabetes, Continuous Glucose Monitors, Telemedicine, Remote Monitoring, Secure Texting, Poorly controlled diabetes
Medical subject headings: Diabetes Mellitus, Type 1, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Continuous Glucose MonitoringOther
Participants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.
Secure textingOther
A secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hemoglobin A1c From Baseline to 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)
Measured: 3 months

Secondary outcomes (1)

Change in Depression Score After Clinical Remote CGM Monitoring and Secure Text Messaging.
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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20211 Dec 2024

First posted7 Sep 2020
Study start1 Nov 2021
Primary completion1 Dec 2024
Study completion1 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04540536
Sponsor's protocol ID: STU-2020-0699
Status last verified: Feb 2026
First submitted: 17 Jul 2020
Last updated: 3 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
ClinicalTrials.gov ID: NCT04540536
Acronym / sponsor ID: STU-2020-0699
Conditions: Diabetes Mellitus, Type 1, Noncompliance, Patient
Keywords: Type 1 Diabetes, Continuous Glucose Monitors, Telemedicine, Remote Monitoring, Secure Texting, Poorly controlled diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: DexCom, Inc.
Study start: 1 Nov 2021 (actual)
Primary completion: 1 Dec 2024 (actual)
Study completion: 1 Dec 2024 (actual)
First posted: 7 Sep 2020 (actual)
Results: Posted 3 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 13 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

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%

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Continuous Glucose MonitoringParticipants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.	Other	–
Secure textingA secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel	Other	–

Primary outcome

Change in Hemoglobin A1c From Baseline to 3 Months
Time frame: 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)

1 secondary outcome

Change in Depression Score After Clinical Remote CGM Monitoring and Secure Text Messaging.
Time frame: 3 months

Results and safety

Results posted to the registry on 3 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Arm	20	11

Primary outcome: Change in Hemoglobin A1c From Baseline to 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: percent

Measure	Real Time Monitoring n = 10
Value	-0.9 (1.1)

Real Time Monitoring: Mean Difference (Final Values): -0.9 (95% CI -1.7 to -0.13), p = 0.03, Paired t test

Population analysed: 1 patient withdrew prior to obtaining this data

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious and other adverse events were reported to the study team at each study visit (at least every 3 months). Serious adverse events were also reported to the study team when or shortly after the event occurred. The side effects were monitored during the duration of the study which was 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Study	1 of 11 (9.1%)	2 of 11 (18.2%)	1 of 11

Limitations and caveats (from the sponsor): This was a pilot study so overall number of participant enrolled and ultimately assigned to the study arm was small.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus, Type 1

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin A1c From Baseline to 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04540536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.