Type1 DiabetesNCT06408207
CGM Academy for Youth With Type 1 Diabetes
A study testing CGM Academy in people with Type1 Diabetes, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring (CGM) device. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Type1 Diabetes
- What is being tested?
- CGM Academy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Current age of 8-18 years, age group eligible for CGM therapy with Dexcom G6 and G7
- T1D duration ≥6 months, as insulin adjustments during honeymoon stage differs from establishedT1D
- Able to speak, read, and write English or Spanish
- Smartphone compatible with Dexcom G6 and G7application
- Ability to participate in virtual visits
Who cannot join
- Known history of medical adhesive allergies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Natalia Garban contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Natalia Garban, ngarban@chla.usc.edu
Rebecca Barber, PhD, RN
About this study
Official title: Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 1 Diabetes
The goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring (CGM) device. The main questions the study aims to answer are:
- Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education?
- Explore relationships between participant's glycemic outcomes with diabetes distress, diabetes family responsibilities, and number of hours of diabetes education.
Read more
Participants in the intervention group will:
- receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies.
- participate in four in-depth online group sessions with diabetes care and education specialists
- complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.
Participants in the comparison group will:
- receive standard education provided to all patients at CHLA
- complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.
Read the detailed description
Youth with type 1 diabetes (T1D) are at increased risk for kidney failure, vision loss, heart disease, and premature mortality due to challenges with glycemic excursions. Continuous glucose monitoring (CGM) systems represent an important advance in diabetes technology with significant advantages over self-monitored blood glucose and the potential to optimize glycemic management. Despite these advances, youth with T1D, including patients at Children's Hospital Los Angeles (CHLA), fail to achieve recommended glycemic targets, highlighting the opportunity for testing innovative diabetes education programs aimed at increased technology uptake such as the CGM Academy intervention.
- Conditions
- Type1 Diabetes
- Being tested
- CGM Academy
- Keywords
- Continuous Glucose Monitoring, Glycemic Control, Diabetes Education, Type1 Diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGM AcademyBehavioural
Educational materials as well as online sessions with diabetes educators.
| Study group | Role | What they receive |
|---|---|---|
| CGM Academy | Experimental | * receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies.
* participate in four in-depth online group sessions with diabetes care and education specialists
* complete questionnaires three times: at the time of study enrollment, week 4 and 6 months. Receives: Behavioral: CGM Academy |
| Standard Diabetes Education | No intervention | * receive standard education provided to all patients at CHLA * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Hemoglobin A1c from baseline to 6 months
Change in Hemoglobin A1c
Measured: Baseline to 6 months
Secondary outcomes (7)
Mean change in HbA1c (%) from baseline to 6 months.
Change in Hemoglobin A1c
Measured: Baseline to 6 months
Mean change in CGM metrics measured by CGM readings
% Glucose Time in Range (70-180 mg/dL), % Glucose Time Below Range (<70mg/dL), % Glucose Time Above Range (>180mg/dL).
Measured: Week 4 & 6 months
Change in perceived diabetes distress at baseline, week 4 & 6 months
The Problem Areas in Diabetes survey (PAID) is an 18-item survey to assess the perceived burden associated with diabetes. Youth and caregivers are given statements about diabetes-related issues and report on a 5-point Likert scale (0 = not a problem, 1 = minor problem, 2 = moderate problem, 3 = somewhat serious problem, 4 = serious problem) the degree to which the statements are a problem for them. Increasing scores denote increased burden perceived.
Measured: Baseline, Week 4 & 6 months
Change in perceived diabetes family responsibility at baseline, week 4 & 6 months.
The Diabetes Family Responsibility Questionnaire (DFRQ) is a 14-item validated survey assessing parental and child involvement in various diabetes management tasks. Youth and caregivers report on a 3-point scale (1=child, 2=equal, 3=parent) who is responsible for a given diabetes task. Higher scores indicate more parental involvement in diabetes management.
Measured: Baseline, week 4 & 6 months
Average number of diabetes educator hours used per study participant at week 4 & 6 months.
Number of hours spent in diabetes education
Measured: Week 4 and 6 months
Perceived benefits of Continuous Glucose Monitor (CGM) use
Adolescent Benefits and Burdens of CGM Survey - BenCGM \& BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.
Measured: week 4 & 6 months
Perceived burden of Continuous Glucose Monitor (CGM) use
Adolescent Benefits and Burdens of CGM Survey - BenCGM \& BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree.
Measured: week 4 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 DiabetesStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simple randomization
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barber, Rebecca, Children's Hospital Los Angeles
- Investigators
- Rebecca Barber, PhD, RN, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408207
- Sponsor's protocol ID
- CHLA-23-00298
- Status last verified
- Jul 2025
- First submitted
- 22 May 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06408207
- Acronym / sponsor ID
- CHLA-23-00298
- Conditions
- Type1 Diabetes
- Keywords
- Continuous Glucose Monitoring, Glycemic Control, Diabetes Education, Type1 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring (CGM) device. The main questions the study aims to answer are:
- Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education?
- Explore relationships between participant's glycemic outcomes with diabetes distress, diabetes family responsibilities, and number of hours of diabetes education.
Participants in the intervention group will:
- receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies.
- participate in four in-depth online group sessions with diabetes care and education specialists
- complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.
Participants in the comparison group will:
- receive standard education provided to all patients at CHLA
- complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.
Detailed description
Youth with type 1 diabetes (T1D) are at increased risk for kidney failure, vision loss, heart disease, and premature mortality due to challenges with glycemic excursions. Continuous glucose monitoring (CGM) systems represent an important advance in diabetes technology with significant advantages over self-monitored blood glucose and the potential to optimize glycemic management. Despite these advances, youth with T1D, including patients at Children's Hospital Los Angeles (CHLA), fail to achieve recommended glycemic targets, highlighting the opportunity for testing innovative diabetes education programs aimed at increased technology uptake such as the CGM Academy intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Simple randomization
| Arm | Type | Receives |
|---|---|---|
| CGM Academy | Experimental | Behavioral: CGM Academy* receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies. * participate in four in-depth online group sessions with diabetes care and education specialists * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months. |
| Standard Diabetes Education | No intervention | –* receive standard education provided to all patients at CHLA * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Current age of 8-18 years, age group eligible for CGM therapy with Dexcom G6 and G7
- T1D duration ≥6 months, as insulin adjustments during honeymoon stage differs from establishedT1D
- Able to speak, read, and write English or Spanish
- Smartphone compatible with Dexcom G6 and G7application
- Ability to participate in virtual visits
Key exclusion criteria (1 listed)
- Known history of medical adhesive allergies
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 |
|---|---|---|
| CGM AcademyEducational materials as well as online sessions with diabetes educators. | Behavioural | CGM Academy |
Primary outcome
Mean change in Hemoglobin A1c from baseline to 6 months
Time frame: Baseline to 6 months
Change in Hemoglobin A1c
7 secondary outcomes
Mean change in HbA1c (%) from baseline to 6 months.
Time frame: Baseline to 6 months
Mean change in CGM metrics measured by CGM readings
Time frame: Week 4 & 6 months
Change in perceived diabetes distress at baseline, week 4 & 6 months
Time frame: Baseline, Week 4 & 6 months
Change in perceived diabetes family responsibility at baseline, week 4 & 6 months.
Time frame: Baseline, week 4 & 6 months
Average number of diabetes educator hours used per study participant at week 4 & 6 months.
Time frame: Week 4 and 6 months
Perceived benefits of Continuous Glucose Monitor (CGM) use
Time frame: week 4 & 6 months
Perceived burden of Continuous Glucose Monitor (CGM) use
Time frame: week 4 & 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Natalia Garban contact
Rebecca Barber, PhD, RN principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM Academy in people with Type1 Diabetes, run by Children's Hospital Los Angeles at 1 site in United States.
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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Barber, PhD, RN ((323) 361-1359 ext. 11359, rbarber@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Hemoglobin A1c from baseline to 6 months (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.