Type 2 DiabetesNCT06516640
Type 2 Continuous Glucose Monitoring Academy
A study testing Continuous Glucose Monitoring Academy and Standard Education in people with Type 2 Diabetes, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D): The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach… Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Continuous Glucose Monitoring Academy and Standard Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Current age of 8-21 years;
- T2D diagnosis;
- Able to speak, read, and write English or Spanish
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.
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 Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes
The goal of this clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D):
- The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach youth with T2D glucose management strategies.
- The second aim is to evaluate the effects of the Continuous Glucose Monitoring Academy metrics.
- The third aim is to explore the relationships between these metrics with diabetes distress, diabetes family responsibilities, and process metrics.
Participants will join for a total of four weeks of education, followed by a six-month clinical review. They will have access to an online workbook and videos, and will participate in virtual sessions with a diabetes educator who will cover glucose management strategies in-depth. Participants will wear their preferred Continuous Glucose Monitoring system (Dexcom or FreeStyle Libre) provided via insurance and inserted at the baseline visit.
- Conditions
- Type 2 Diabetes
- Being tested
- Continuous Glucose Monitoring Academy, Standard Education
- Keywords
- Continuous Glucose Monitoring, Glycemic Control, Diabetes Education, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring AcademyBehavioural
Educational materials as well as online sessions with diabetes educators.
Standard EducationBehavioural
Also called Standard of Care
Standard of care receives general education about diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Receives standard of care, regular education in the clinic. Receives: Behavioral: Standard Education |
| Continuous Glucose Monitoring Academy | Experimental | Receive an interactive workbook with problem-based learning scenarios and video links about Continuous Glucose Monitoring and glucose management strategies (CGM Academy Program). 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: Continuous Glucose Monitoring Academy; Behavioral: Standard Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Time in Range (TIR) from baseline to 6 months
Change in % glucose TIR (70-180 mg/dL)
Measured: Baseline to 6 months
Secondary outcomes (7)
Mean change in Hemoglobin A1c (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 Below Range (<70mg/dL), % Glucose Time Above Range (>180mg/dL), % Glucose Variability (coefficient of variation, CV)
Measured: Week 4 & 6 months
Change in perceived diabetes distress at baseline, week 4 & 6 months
The Type 2 Diabetes Distress Assessment System (T2-DDAS) measures how much overall emotional distress is due to diabetes. Respondents are given statements about diabetes-related issues and indicate 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. 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
Mean change in perceived benefits of Continuous Glucose (CGM) Monitor use
Name of questionnaire: 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
Mean change in perceived burden of Continuous Glucose Monitor (CGM) use
Name of questionnaire: 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 posted24 Jul 2024
- Study start23 Jun 2025
- Primary completion1 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 Type 2 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- 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
- NCT06516640
- Sponsor's protocol ID
- CHLA-24-00199
- Other IDs
- P50MD017344
- Status last verified
- Jul 2025
- First submitted
- 11 Jun 2024
- 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 Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06516640
- Acronym / sponsor ID
- CHLA-24-00199
- Conditions
- Type 2 Diabetes
- Keywords
- Continuous Glucose Monitoring, Glycemic Control, Diabetes Education, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Jul 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 clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D):
- The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach youth with T2D glucose management strategies.
- The second aim is to evaluate the effects of the Continuous Glucose Monitoring Academy metrics.
- The third aim is to explore the relationships between these metrics with diabetes distress, diabetes family responsibilities, and process metrics.
Participants will join for a total of four weeks of education, followed by a six-month clinical review. They will have access to an online workbook and videos, and will participate in virtual sessions with a diabetes educator who will cover glucose management strategies in-depth. Participants will wear their preferred Continuous Glucose Monitoring system (Dexcom or FreeStyle Libre) provided via insurance and inserted at the baseline visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Standard EducationReceives standard of care, regular education in the clinic. |
| Continuous Glucose Monitoring Academy | Experimental | Behavioral: Continuous Glucose Monitoring Academy, Behavioral: Standard EducationReceive an interactive workbook with problem-based learning scenarios and video links about Continuous Glucose Monitoring and glucose management strategies (CGM Academy Program). 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. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Current age of 8-21 years;
- T2D diagnosis;
- Able to speak, read, and write English or Spanish
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 |
|---|---|---|
| Continuous Glucose Monitoring AcademyEducational materials as well as online sessions with diabetes educators. | Behavioural | Continuous Glucose Monitoring Academy |
| Standard EducationAlso: Standard of CareStandard of care receives general education about diabetes. | Behavioural | Continuous Glucose Monitoring Academy, Control |
Primary outcome
Mean change in Time in Range (TIR) from baseline to 6 months
Time frame: Baseline to 6 months
Change in % glucose TIR (70-180 mg/dL)
7 secondary outcomes
Mean change in Hemoglobin A1c (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
Mean change in perceived benefits of Continuous Glucose (CGM) Monitor use
Time frame: Week 4 & 6 months
Mean change in 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.
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 Continuous Glucose Monitoring Academy and Standard Education in people with Type 2 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 3 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. Some participants in this study may receive a placebo. 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 Natalia Garban (3233611359, ngarban@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 Time in Range (TIR) 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.