Type 1 DiabetesROUTE-T1DNCT05564481
Research on Optimizing the Use of Technology With Education
A study testing diabetes education and parent coaching support in people with Type 1 Diabetes and Continuous Glucose Monitoring, run by Children's National Research Institute at 1 site in United States.
Trial summary
Consistent use of continuous glucose monitors (CGM) has the potential to improve glycemic control and related type 1 diabetes (T1D) health outcomes, however young adolescents with T1D are the least likely age group to begin and sustain use of CGM. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Type 1 Diabetes, Continuous Glucose Monitoring, Behavioral Intervention
- What is being tested?
- diabetes education and parent coaching support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 1 Jan 2025
- 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 10-15 years old
- Type 1 diabetes
- Type 1 diabetes diagnosis ≥ 6 months \
- Starting a continuous glucose monitor for the first time or restarting after ≥ 1 year
Who cannot join
- Younger than 10, older than 15
- Diagnosed less than 6 months
- Already using CGM or has used within last year
- Other major medical condition such as cancer, cystic fibrosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Optimizing Technology Uptake and Use in Hard to Reach Adolescents With Type 1 Diabetes
Consistent use of continuous glucose monitors (CGM) has the potential to improve glycemic control and related type 1 diabetes (T1D) health outcomes, however young adolescents with T1D are the least likely age group to begin and sustain use of CGM. The proposed study will conduct a feasibility trial of a behavioral intervention designed to optimize use of CGM in adolescents specifically targeting underrepresented populations in diabetes technology research.
Read the detailed description
Young adolescents (ages 10-15) with type 1 diabetes (T1D) are at high risk for deterioration of glycemic control and relatedly poor overall T1D self-management. Continuous glucose monitors (CGM) provide real-time indicators of glucose levels and alert users to hypoglycemia and hyperglycemia. Consistent, informed use of CGM has the potential to improve glycemic control and related T1D health outcomes. However, adolescents with T1D are the least likely age group to utilize CGM and significant health disparities exist in access to and use of CGM among youth from racial and ethnic minority backgrounds and youth with public insurance. Adolescent CGM users also continue to evidence A1c levels above recommended targets, potentially due challenges related to perceived CGM burden and related family functioning. Novel, developmentally targeted interventions delivered early in adolescence could promote optimal uptake and use of CGM and reduce psychosocial barriers to sustained use but must be evaluated in rigorous pilot trials that attend to health disparities. The current study proposes to evaluate an innovative behavioral intervention that utilizes certified diabetes care and education specialists (CDCES) to teach problem-solving and communication skills around CGM data and use, targeting adolescent-parent T1D interactions related to glucose data, individualized CGM challenges, and weekly adolescent-parent joint review of CGM reports. The intervention also addresses HCP knowledge of health disparities in diabetes technology through interactive education, and boosts family support through connection with peer parent consultants. This study aims to evaluate the preliminary efficacy of the behavioral intervention to enhance CGM use and resulting T1D health outcomes. Sixty adolescents and their parents (using a dyad study design) will be recruited for this pilot randomized trial, randomly assigned to either an immediate intervention group or a delayed intervention group serving as a standard care comparison. Intervention content will be delivered via 3 telemedicine sessions with adolescents and a parent and supported by connection with a peer parent consultant. Medical and psychosocial data (including A1c, CGM indicators, CGM burdens and benefits, diabetes distress, and diabetes-related family conflict) will be collected from adolescents and a parent at baseline and three follow-up time points across the first year after CGM initiation. The investigators will employ quantitative and qualitative analyses to evaluate intervention feasibility, acceptability, and impact. Enhancing CGM access and use at this key developmental juncture provides an excellent opportunity for tailored support and problem-solving, resulting in potentially lasting improvement in diabetes self-management. Results of this pilot trial will directly inform a multi-site randomized clinical trial to evaluate efficacy, with the long term goal of identifying effective behavioral strategies that can be integrated into routine diabetes education and care.
- Conditions
- Type 1 Diabetes, Continuous Glucose Monitoring, Behavioral Intervention, Parent-Child Relations
- Being tested
- diabetes education and parent coaching support
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetes education and parent coaching supportBehavioural
Intervention sessions will include parent/child discussion about barriers to CGM use, review of CGM data, problem solving, and working as a team.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Experimental | Participants randomized to the immediate intervention group will participate in 3 video-conferencing sessions with a Certified Diabetes Care and Education Specialist (CDCES) interventionist and connect with a peer parent consultant immediately post randomization (expected intervention duration: 3 months). Receives: Behavioral: diabetes education and parent coaching support |
| Wait-list/delayed intervention | Active comparator | Participants randomized to the delayed intervention group will receive no intervention for 6 months post-randomization; after the 6-month follow-up period, the delayed intervention group also will participate in 3 video conferencing sessions with a CDCES interventionist and connect with a peer parent consultant (expected intervention duration: 3 months). Receives: Behavioral: diabetes education and parent coaching support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
Hemoglobin A1c (HbA1c)
Measured: 6 months post-randomization
Glycemic Control
Hemoglobin A1c (HbA1c)
Measured: 12 months post-randomization
CGM Time-in-range
CGM time-in-range is the amount of time a person with diabetes spends in a target glucose range of 70 and 180 mg/dL. The time frame used was 90-day CGM data, with the end date of the 90 days being the 6-month timepoint start date.
Measured: 6 months post-randomization
CGM Time-in-range
CGM time-in-range is the amount of time a person with diabetes spends in a target glucose range of 70 and 180 mg/dL. The time frame used was 90-day CGM data, with the end date of the 90 days being the 12-month timepoint start date.
Measured: 12 months post-randomization
CGM Wear-time
The duration of time that the CGM is worn on the body. The time frame used was 90-day CGM data, with the end date of the 90 days being the 6-month timepoint start date.
Measured: 6 months post randomization
CGM Wear-time
The duration of time that the CGM is worn on the body. The time frame used was 90-day CGM data, with the end date of the 90 days being the 12-month timepoint start date.
Measured: 12 months post-randomization
Secondary outcomes (16)
Caregiver-Reported Family Conflict
The Diabetes Family Conflict Scale-Revised (DFCS-R) was used to measure diabetes-related family conflict. Total scores are reported below. The DFCS-R is on a scale of 19-57, where a higher score indicates higher family conflict. 6-month caregiver-reported diabetes family conflict is reported here.
Measured: 6 months post-randomization
Caregiver-Reported Family Conflict
The Diabetes Family Conflict Scale-Revised (DFCS-R) was used to measure diabetes-related family conflict. Total scores are reported below. The DFCS-R is on a scale of 19-57, where a higher score indicates higher family conflict. 12-month caregiver-reported diabetes family conflict is reported here.
Measured: 12 months post-randomization
Youth-Reported Family Conflict
The Diabetes Family Conflict Scale-Revised (DFCS-R) was used to measure diabetes-related family conflict. Total scores are reported below. The DFCS-R is on a scale of 19-57, where a higher score indicates higher family conflict. 6-month youth-reported diabetes family conflict is reported here.
Measured: 6 months post-randomization
Youth-Reported Family Conflict
The Diabetes Family Conflict Scale-Revised (DFCS-R) was used to measure diabetes-related family conflict. Total scores are reported below. The DFCS-R is on a scale of 19-57, where a higher score indicates higher family conflict. 12-month youth-reported diabetes family conflict is reported here.
Measured: 12 months post-randomization
Caregiver CGM Benefits and Burdens
The Benefits and Burdens of CGM (Ben/Bur CGM) questionnaire includes two 8-item scales (benefits, burdens) that provide important patient-reported outcome metrics to further understand complex behaviors related to adherence to CGM use and diabetes self-management. Each questionnaire (benefits, burdens) contains eight items which are rated on a Likert scale, one to five. 1 is strongly disagree and 5 is strongly agree. Mean total scores for each scale as well as mean scores for each item may be analyzed. Scores range from 1-5 for each item/subscale and for the overall score. Higher mean score on the benefits scale indicates higher perceived benefits while higher mean scores on the burdens scales indicated higher perceived burdens. 6-month caregiver-reported Ben/Bur CGM is reported here.
Measured: 6 months post randomization
Caregiver CGM Benefits and Burdens
The Benefits and Burdens of CGM (Ben/Bur CGM) questionnaire includes two 8-item scales (benefits, burdens) that provide important patient-reported outcome metrics to further understand complex behaviors related to adherence to CGM use and diabetes self-management. Each questionnaire (benefits, burdens) contains eight items which are rated on a Likert scale, one to five. 1 is strongly disagree and 5 is strongly agree. Mean total scores for each scale as well as mean scores for each item may be analyzed. Scores range from 1-5 for each item/subscale and for the overall score. Higher mean score on the benefits scale indicates higher perceived benefits while higher mean scores on the burdens scales indicated higher perceived burdens. 12-month caregiver-reported Ben/Bur CGM is reported here.
Measured: 12 months post randomization
Youth CGM Benefits and Burdens
The Benefits and Burdens of CGM (Ben/Bur CGM) questionnaire includes two 8-item scales (benefits, burdens) that provide important patient-reported outcome metrics to further understand complex behaviors related to adherence to CGM use and diabetes self-management. Each questionnaire (benefits, burdens) contains eight items which are rated on a Likert scale, one to five. 1 is strongly disagree and 5 is strongly agree. Mean total scores for each scale as well as mean scores for each item may be analyzed. Scores range from 1-5 for each item/subscale and for the overall score. Higher mean score on the benefits scale indicates higher perceived benefits while higher mean scores on the burdens scales indicated higher perceived burdens. 6-month youth-reported Ben/Bur CGM is reported here.
Measured: 6 months post randomization
Youth CGM Benefits and Burdens
The Benefits and Burdens of CGM (Ben/Bur CGM) questionnaire includes two 8-item scales (benefits, burdens) that provide important patient-reported outcome metrics to further understand complex behaviors related to adherence to CGM use and diabetes self-management. Each questionnaire (benefits, burdens) contains eight items which are rated on a Likert scale, one to five. 1 is strongly disagree and 5 is strongly agree. Mean total scores for each scale as well as mean scores for each item may be analyzed. Scores range from 1-5 for each item/subscale and for the overall score. Higher mean score on the benefits scale indicates higher perceived benefits while higher mean scores on the burdens scales indicated higher perceived burdens. 12-month youth-reported Ben/Bur CGM is reported here.
Measured: 12 months post randomization
Child/Teen Diabetes Distress
Problem Areas in Diabetes Children (PAID-C) and Teen (PAID-T) versions measure diabetes-specific emotional distress for children and adolescents. Responses target how much each diabetes-related experience bothers/upsets the individual respondent over the past month. Items are summed to create an overall distress score, with higher scores indicating greater emotional distress. For the PAID-T and PAID-C, higher scores reflect greater diabetes-specific diabetes distress for both teens and children. Scores range from 14-84 for the PAID-T and 11-66 for the PAID-C. To address the unequal sample sizes between the PAID-C (n=19) and PAID-T (n=41), scores were normalized by converting the raw scores into percentages of the maximum possible score for each version. This normalization ensured that both the child and teen versions of the PAID were on the same scale (0-100%), allowing for more accurate comparisons across groups and improving statistical power. Data here is for youth at 6-months.
Measured: 6 months post-randomization
Child/Teen Diabetes Distress
Problem Areas in Diabetes Children (PAID-C) and Teen (PAID-T) versions measure diabetes-specific emotional distress for children and adolescents. Responses target how much each diabetes-related experience bothers/upsets the individual respondent over the past month. Items are summed to create an overall distress score, with higher scores indicating greater emotional distress. For the PAID-T and PAID-C, higher scores reflect greater diabetes-specific diabetes distress for both teens and children. Scores range from 14-84 for the PAID-T and 11-66 for the PAID-C. To address the unequal sample sizes between the PAID-C (n=19) and PAID-T (n=41), scores were normalized by converting the raw scores into percentages of the maximum possible score for each version. This normalization ensured that both the child and teen versions of the PAID were on the same scale (0-100%), allowing for more accurate comparisons across groups and improving statistical power. 12-month youth date is presented here.
Measured: 12 months post-randomization
Caregiver Diabetes Distress
The Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR) assesses the perceived parental burden associated with caring for a child with diabetes. Responses target how much each diabetes-related experience bothers/upsets the individual respondent over the past month. Each of the 18 items is reverse scored (0 to 4, 1 to 3, etc.), then you calculate the mean of all non-missing items. That mean is multiplied by 25 to produce a total score ranging from 0 to 100, with higher scores indicating greater parent diabetes-related distress. 6-month caregiver-reported diabetes distress is reported here.
Measured: 6 months post-randomization
Caregiver Diabetes Distress
The Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR) assesses the perceived parental burden associated with caring for a child with diabetes. Responses target how much each diabetes-related experience bothers/upsets the individual respondent over the past month. Each of the 18 items is reverse scored (0 to 4, 1 to 3, etc.), then you calculate the mean of all non-missing items. That mean is multiplied by 25 to produce a total score ranging from 0 to 100, with higher scores indicating greater parent diabetes-related distress. 12-month caregiver-reported diabetes distress is reported here.
Measured: 12 months post-randomization
Caregiver-Reported Diabetes Self-Management
The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month. Scored 0-100 with higher scores indicating higher adherence to diabetes management. 6-month caregiver-reported Diabetes Self-Management is reported here.
Measured: 6 months post-randomization
Caregiver-Reported Diabetes Self-Management
The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month. Scored 0-100 with higher scores indicating higher adherence to diabetes management. 12-month caregiver-reported Diabetes Self-Management is reported here.
Measured: 12 months post-randomization
Youth-Reported Diabetes Self-Management
The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month. Scored 0-100 with higher scores indicating higher adherence to diabetes management. 6-month youth-reported Diabetes Self-Management is reported here.
Measured: 6 months post-randomization
Youth-Reported Diabetes Self-Management
The Diabetes Management Questionnaire (DMQ)-a self- and parent-report measure assessing the frequency of engagement in diabetes care behaviors (e.g. BG monitoring, adjusting behavior to specific situations) over the past month. Scored 0-100 with higher scores indicating higher adherence to diabetes management. 12-month youth-reported Diabetes Self-Management is reported here.
Measured: 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start7 Sep 2022
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
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 Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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
- wait-list control; all youth-caregiver dyads receive intervention- randomized to start immediately or 6 months after CGM start
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randi Streisand, Children's National Research Institute
- Investigators
- Randi Streisand, PhD, Principal investigator, Children's National Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564481
- Sponsor's protocol ID
- Pro00016314
- Acronym
- ROUTE-T1D
- Status last verified
- Jul 2026
- First submitted
- 26 Aug 2022
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Technology Uptake and Use in Hard to Reach Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05564481
- Acronym / sponsor ID
- ROUTE-T1D / Pro00016314
- Conditions
- Type 1 Diabetes, Continuous Glucose Monitoring, Behavioral Intervention, Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Posted 22 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Consistent use of continuous glucose monitors (CGM) has the potential to improve glycemic control and related type 1 diabetes (T1D) health outcomes, however young adolescents with T1D are the least likely age group to begin and sustain use of CGM. The proposed study will conduct a feasibility trial of a behavioral intervention designed to optimize use of CGM in adolescents specifically targeting underrepresented populations in diabetes technology research.
Detailed description
Young adolescents (ages 10-15) with type 1 diabetes (T1D) are at high risk for deterioration of glycemic control and relatedly poor overall T1D self-management. Continuous glucose monitors (CGM) provide real-time indicators of glucose levels and alert users to hypoglycemia and hyperglycemia. Consistent, informed use of CGM has the potential to improve glycemic control and related T1D health outcomes. However, adolescents with T1D are the least likely age group to utilize CGM and significant health disparities exist in access to and use of CGM among youth from racial and ethnic minority backgrounds and youth with public insurance. Adolescent CGM users also continue to evidence A1c levels above recommended targets, potentially due challenges related to perceived CGM burden and related family functioning. Novel, developmentally targeted interventions delivered early in adolescence could promote optimal uptake and use of CGM and reduce psychosocial barriers to sustained use but must be evaluated in rigorous pilot trials that attend to health disparities. The current study proposes to evaluate an innovative behavioral intervention that utilizes certified diabetes care and education specialists (CDCES) to teach problem-solving and communication skills around CGM data and use, targeting adolescent-parent T1D interactions related to glucose data, individualized CGM challenges, and weekly adolescent-parent joint review of CGM reports. The intervention also addresses HCP knowledge of health disparities in diabetes technology through interactive education, and boosts family support through connection with peer parent consultants. This study aims to evaluate the preliminary efficacy of the behavioral intervention to enhance CGM use and resulting T1D health outcomes. Sixty adolescents and their parents (using a dyad study design) will be recruited for this pilot randomized trial, randomly assigned to either an immediate intervention group or a delayed intervention group serving as a standard care comparison. Intervention content will be delivered via 3 telemedicine sessions with adolescents and a parent and supported by connection with a peer parent consultant. Medical and psychosocial data (including A1c, CGM indicators, CGM burdens and benefits, diabetes distress, and diabetes-related family conflict) will be collected from adolescents and a parent at baseline and three follow-up time points across the first year after CGM initiation. The investigators will employ quantitative and qualitative analyses to evaluate intervention feasibility, acceptability, and impact. Enhancing CGM access and use at this key developmental juncture provides an excellent opportunity for tailored support and problem-solving, resulting in potentially lasting improvement in diabetes self-management. Results of this pilot trial will directly inform a multi-site randomized clinical trial to evaluate efficacy, with the long term goal of identifying effective behavioral strategies that can be integrated into routine diabetes education and care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- wait-list control; all youth-caregiver dyads receive intervention- randomized to start immediately or 6 months after CGM start
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention | Experimental | Behavioral: diabetes education and parent coaching supportParticipants randomized to the immediate intervention group will participate in 3 video-conferencing sessions with a Certified Diabetes Care and Education Specialist (CDCES) interventionist and connect with a peer parent consultant immediately post randomization (expected intervention duration: 3 months). |
| Wait-list/delayed intervention | Active comparator | Behavioral: diabetes education and parent coaching supportParticipants randomized to the delayed intervention group will receive no intervention for 6 months post-randomization; after the 6-month follow-up period, the delayed intervention group also will participate in 3 video conferencing sessions with a CDCES interventionist and connect with a peer parent consultant (expected intervention duration: 3 months). |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 10-15 years old
- Type 1 diabetes
- Type 1 diabetes diagnosis ≥ 6 months \
- Starting a continuous glucose monitor for the first time or restarting after ≥ 1 year
Key exclusion criteria (4 listed)
- Younger than 10, older than 15
- Diagnosed less than 6 months
- Already using CGM or has used within last year
- Other major medical condition such as cancer, cystic fibrosis
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 |
|---|---|---|
| diabetes education and parent coaching supportIntervention sessions will include parent/child discussion about barriers to CGM use, review of CGM data, problem solving, and working as a team. | Behavioural | Immediate intervention, Wait-list/delayed intervention |
Primary outcome
Glycemic Control
Time frame: 6 months post-randomization
Hemoglobin A1c (HbA1c)
Glycemic Control
Time frame: 12 months post-randomization
Hemoglobin A1c (HbA1c)
CGM Time-in-range
Time frame: 6 months post-randomization
CGM time-in-range is the amount of time a person with diabetes spends in a target glucose range of 70 and 180 mg/dL. The time frame used was 90-day CGM data, with the end date of the 90 days being the 6-month timepoint start date.
CGM Time-in-range
Time frame: 12 months post-randomization
CGM time-in-range is the amount of time a person with diabetes spends in a target glucose range of 70 and 180 mg/dL. The time frame used was 90-day CGM data, with the end date of the 90 days being the 12-month timepoint start date.
CGM Wear-time
Time frame: 6 months post randomization
The duration of time that the CGM is worn on the body. The time frame used was 90-day CGM data, with the end date of the 90 days being the 6-month timepoint start date.
CGM Wear-time
Time frame: 12 months post-randomization
The duration of time that the CGM is worn on the body. The time frame used was 90-day CGM data, with the end date of the 90 days being the 12-month timepoint start date.
16 secondary outcomes
Caregiver-Reported Family Conflict
Time frame: 6 months post-randomization
Caregiver-Reported Family Conflict
Time frame: 12 months post-randomization
Youth-Reported Family Conflict
Time frame: 6 months post-randomization
Youth-Reported Family Conflict
Time frame: 12 months post-randomization
Caregiver CGM Benefits and Burdens
Time frame: 6 months post randomization
Caregiver CGM Benefits and Burdens
Time frame: 12 months post randomization
Youth CGM Benefits and Burdens
Time frame: 6 months post randomization
Youth CGM Benefits and Burdens
Time frame: 12 months post randomization
Child/Teen Diabetes Distress
Time frame: 6 months post-randomization
Child/Teen Diabetes Distress
Time frame: 12 months post-randomization
Caregiver Diabetes Distress
Time frame: 6 months post-randomization
Caregiver Diabetes Distress
Time frame: 12 months post-randomization
Caregiver-Reported Diabetes Self-Management
Time frame: 6 months post-randomization
Caregiver-Reported Diabetes Self-Management
Time frame: 12 months post-randomization
Youth-Reported Diabetes Self-Management
Time frame: 6 months post-randomization
Youth-Reported Diabetes Self-Management
Time frame: 12 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Randi Streisand, PhD principal investigator
Children's National Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diabetes education and parent coaching support in people with Type 1 Diabetes and Continuous Glucose Monitoring, run by Children's National Research Institute 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 4 inclusion and 4 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 22 Oct 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?
Yes. Results are posted in the registry (first posted 22 Oct 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?
Glycemic Control (time frame: 6 months post-randomization). The study lists 6 primary outcomes in all. 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 22 Oct 2026.