Type 1 Diabetes MellitusNCT03734107
Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care
A study testing Plan, Reflect, and Engage with Providers for Diabetes Care in people with Type 1 Diabetes Mellitus, run by Children's National Research Institute at 1 site in United States.
Trial summary
Adolescents and young adults (AYAs; ages 17-23) with type 1 diabetes are at high risk for negative health outcomes, including poor glycemic control and disengagement from the health care system. Read more about this study
- Who is it for?
- Ages 17 to 23 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Plan, Reflect, and Engage with Providers for Diabetes Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 2 Jan 2026
- 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 17 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with type1 diabetes for ≥ 1 year
- Able to adequately understand, speak, and read English to benefit from participation
- Ready and consistent text messaging access to participate
- Within 6-8 months of planned transfer to adult diabetes care
Who cannot join
- Other life-threatening disease (e.g. cancer) or major psychiatric disorder (e.g. schizophrenia) that significantly limits participation
- Pervasive developmental disorder that significantly limits participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Adolescents and young adults (AYAs; ages 17-23) with type 1 diabetes are at high risk for negative health outcomes, including poor glycemic control and disengagement from the health care system. The deterioration of glycemic control occurs in parallel with the assumption of independent self-care skills and preparation for adult diabetes care. Effective communication between AYAs and health care providers may be a critical contributor to diabetes self-care skills during the transition to adult diabetes care and related glycemic control. This research will attempt to better prepare adolescents and young adults for adult diabetes care by delivering innovative intervention content focused on both health communication skills and transition readiness skills. The investigators aim to leverage innovative technologies to improve developmentally-appropriate communication skills related to planning for clinic visits, disclosing and discussing diabetes-related concerns, and optimizing glucose data review in preparation for adult diabetes care. Adolescents and young adults with type 1 diabetes (ages 17-23) who are planning to transition to adult diabetes care within the next 6-8 months will be enrolled in the study and randomized to either the intervention group or a standard care control group. Medical, communication and psychosocial data (including A1c, glucose monitoring frequency, communication quality, health care engagement, depressive symptoms) will be collected from adolescent and young adult participants and health care providers at baseline and two follow-up time points, approximately 4 months post-baseline and approximately 8-12 months post-baseline after the transfer to adult diabetes care. This intervention has the potential to improve diabetes self-care skills, including engagement with health care providers, and glycemic control in AYAs with type 1 diabetes during the vulnerable period of transfer to adult diabetes care. The results of this work will inform best practices for the transition to adult diabetes care and can be translated into clinical care.
Read the detailed description
Research Design and Methods Overview of Study Design \& Procedure. The aim of this randomized controlled trial (RCT) is to determine the efficacy of a behavioral intervention targeting health communication skills and diabetes self-management skills in preparation for the transfer to adult diabetes care, compared to usual care. The intervention, Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC), consists of three intervention sessions with a study interventionist, paired text messages, and access to glucose management software. It is expected that adolescents and young adults allocated to the intervention condition (PREP-DC) will evidence: 1) better glycemic control (lower A1c); 2) shorter gap in time between the last visit in pediatric diabetes care and the first visit in adult diabetes care; 3) better diabetes management (better adherence to the diabetes regimen); 4) fewer reported complications (e.g. hospitalizations and emergency department visits). A total of 100 adolescent and young adult participants (ages 17-23) will be randomly allocated in a 1:1 ratio to either the PREP-DC intervention condition (n=50) or usual care (n=50; standard care comparison condition): all participants receive standard resources for transition to adult diabetes care as part of usual care in both conditions.
Participants include 100 adolescents and young adults (ages 17-23) diagnosed with T1D for at least one year (anticipated 50% female) seen for diabetes care at Children's National Medical Center (CNMC) in Washington, DC. Eligible participants will self-identify as planning to transfer to adult diabetes care within the upcoming 6-8 months. Participants in the PREP-DC intervention will complete three intervention sessions with study team members over a 3 month period (approximately 1 intervention session per month). Two sessions will be with a trained study interventionist focusing on communication with health care providers and preparation for medical visits and adult diabetes care. One session will be with a certified diabetes education focusing on problem-solving using glucose data and glucose data review. PREP-DC intervention participants will also receive text messages (3-4 messages/week) for the 3 month intervention period supporting intervention content. Participants also will be given information about accessing glucose management software specific to their diabetes devices and related study resources (e.g. study website). Participants are evaluated at baseline (pre-randomization to intervention or standard care comparison group) and follow-up (approximately 4 months post-baseline and approximately 8-12 months post-baseline after the transition to adult diabetes care).
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Plan, Reflect, and Engage with Providers for Diabetes Care
- Keywords
- transition to adult medical care, adolescents and young adults, health communication, adherence, type 1 diabetes
- 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.
Plan, Reflect, and Engage with Providers for Diabetes CareBehavioural
Also called PREP-DC
Behavioral intervention designed to improve health communication skills and readiness for adult diabetes care
| Study group | Role | What they receive |
|---|---|---|
| PREP-DC Intervention | Experimental | 50 participants will be randomized to the Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC) intervention. Participants will complete 3 intervention sessions with study interventionists and will receive text messages and other study resources during the active intervention period (3 months). Receives: Behavioral: Plan, Reflect, and Engage with Providers for Diabetes Care |
| Standard Care Comparison | No intervention | 50 participants will be randomized to standard care and will participate in regular diabetes clinic visits and receive standard materials on the transition to adult diabetes care, as they would have done without participation in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
percentage of glycated hemoglobin (Hemoglobin A1c)
Measured: 8 months post-baseline
Number of Days to First Adult Diabetes Care Visit
Number of days between the last visit in pediatric diabetes care and the first visit in adult diabetes care (reported as number of days).
Measured: 8 months post-baseline
Adherence to the Diabetes Care Regimen
Participant report on the Diabetes Management Questionnaire (DMQ), a self-report measure of adherence to the diabetes care regimen. The DMQ consists of 20 items scored on a 0-4 Likert Scale. The measure has a total score; the mean score on all items is calculated and multiplied by 25 to arrive at the total score (possible range 0-100). A higher score indicates greater adherence to diabetes management.
Measured: 8 months post-baseline
Diabetes-related Hospitalizations
Participant report and medical record review of reported diabetes-related hospitalizations for the duration of the study period. The total number of diabetes-related emergency department visits/hospitalizations is summed.
Measured: 8 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start6 Nov 2018
- Primary completion1 Dec 2023
- Study completion2 Jan 2026
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 Diabetes MellitusStudies 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
- Participants are randomized in a 1:1 ratio to the intervention group or standard care comparison group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Randi Streisand, Children's National Research Institute
- Investigators
- Randi Streisand, PhD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734107
- Sponsor's protocol ID
- 30004426
- Status last verified
- May 2026
- First submitted
- 1 Nov 2018
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care
- ClinicalTrials.gov ID
- NCT03734107
- Acronym / sponsor ID
- 30004426
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- transition to adult medical care, adolescents and young adults, health communication, adherence, type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 2 Jan 2026 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescents and young adults (AYAs; ages 17-23) with type 1 diabetes are at high risk for negative health outcomes, including poor glycemic control and disengagement from the health care system. The deterioration of glycemic control occurs in parallel with the assumption of independent self-care skills and preparation for adult diabetes care. Effective communication between AYAs and health care providers may be a critical contributor to diabetes self-care skills during the transition to adult diabetes care and related glycemic control. This research will attempt to better prepare adolescents and young adults for adult diabetes care by delivering innovative intervention content focused on both health communication skills and transition readiness skills. The investigators aim to leverage innovative technologies to improve developmentally-appropriate communication skills related to planning for clinic visits, disclosing and discussing diabetes-related concerns, and optimizing glucose data review in preparation for adult diabetes care. Adolescents and young adults with type 1 diabetes (ages 17-23) who are planning to transition to adult diabetes care within the next 6-8 months will be enrolled in the study and randomized to either the intervention group or a standard care control group. Medical, communication and psychosocial data (including A1c, glucose monitoring frequency, communication quality, health care engagement, depressive symptoms) will be collected from adolescent and young adult participants and health care providers at baseline and two follow-up time points, approximately 4 months post-baseline and approximately 8-12 months post-baseline after the transfer to adult diabetes care. This intervention has the potential to improve diabetes self-care skills, including engagement with health care providers, and glycemic control in AYAs with type 1 diabetes during the vulnerable period of transfer to adult diabetes care. The results of this work will inform best practices for the transition to adult diabetes care and can be translated into clinical care.
Detailed description
Research Design and Methods Overview of Study Design \& Procedure. The aim of this randomized controlled trial (RCT) is to determine the efficacy of a behavioral intervention targeting health communication skills and diabetes self-management skills in preparation for the transfer to adult diabetes care, compared to usual care. The intervention, Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC), consists of three intervention sessions with a study interventionist, paired text messages, and access to glucose management software. It is expected that adolescents and young adults allocated to the intervention condition (PREP-DC) will evidence: 1) better glycemic control (lower A1c); 2) shorter gap in time between the last visit in pediatric diabetes care and the first visit in adult diabetes care; 3) better diabetes management (better adherence to the diabetes regimen); 4) fewer reported complications (e.g. hospitalizations and emergency department visits). A total of 100 adolescent and young adult participants (ages 17-23) will be randomly allocated in a 1:1 ratio to either the PREP-DC intervention condition (n=50) or usual care (n=50; standard care comparison condition): all participants receive standard resources for transition to adult diabetes care as part of usual care in both conditions.
Participants include 100 adolescents and young adults (ages 17-23) diagnosed with T1D for at least one year (anticipated 50% female) seen for diabetes care at Children's National Medical Center (CNMC) in Washington, DC. Eligible participants will self-identify as planning to transfer to adult diabetes care within the upcoming 6-8 months. Participants in the PREP-DC intervention will complete three intervention sessions with study team members over a 3 month period (approximately 1 intervention session per month). Two sessions will be with a trained study interventionist focusing on communication with health care providers and preparation for medical visits and adult diabetes care. One session will be with a certified diabetes education focusing on problem-solving using glucose data and glucose data review. PREP-DC intervention participants will also receive text messages (3-4 messages/week) for the 3 month intervention period supporting intervention content. Participants also will be given information about accessing glucose management software specific to their diabetes devices and related study resources (e.g. study website). Participants are evaluated at baseline (pre-randomization to intervention or standard care comparison group) and follow-up (approximately 4 months post-baseline and approximately 8-12 months post-baseline after the transition to adult diabetes care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to the intervention group or standard care comparison group
| Arm | Type | Receives |
|---|---|---|
| PREP-DC Intervention | Experimental | Behavioral: Plan, Reflect, and Engage with Providers for Diabetes Care50 participants will be randomized to the Plan, Reflect, and Engage with Providers for Diabetes Care (PREP-DC) intervention. Participants will complete 3 intervention sessions with study interventionists and will receive text messages and other study resources during the active intervention period (3 months). |
| Standard Care Comparison | No intervention | –50 participants will be randomized to standard care and will participate in regular diabetes clinic visits and receive standard materials on the transition to adult diabetes care, as they would have done without participation in this study. |
Who may qualify
- Ages
- 17 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with type1 diabetes for ≥ 1 year
- Able to adequately understand, speak, and read English to benefit from participation
- Ready and consistent text messaging access to participate
- Within 6-8 months of planned transfer to adult diabetes care
Key exclusion criteria (2 listed)
- Other life-threatening disease (e.g. cancer) or major psychiatric disorder (e.g. schizophrenia) that significantly limits participation
- Pervasive developmental disorder that significantly limits participation
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 |
|---|---|---|
| Plan, Reflect, and Engage with Providers for Diabetes CareAlso: PREP-DCBehavioral intervention designed to improve health communication skills and readiness for adult diabetes care | Behavioural | PREP-DC Intervention |
Primary outcome
Hemoglobin A1c
Time frame: 8 months post-baseline
percentage of glycated hemoglobin (Hemoglobin A1c)
Number of Days to First Adult Diabetes Care Visit
Time frame: 8 months post-baseline
Number of days between the last visit in pediatric diabetes care and the first visit in adult diabetes care (reported as number of days).
Adherence to the Diabetes Care Regimen
Time frame: 8 months post-baseline
Participant report on the Diabetes Management Questionnaire (DMQ), a self-report measure of adherence to the diabetes care regimen. The DMQ consists of 20 items scored on a 0-4 Likert Scale. The measure has a total score; the mean score on all items is calculated and multiplied by 25 to arrive at the total score (possible range 0-100). A higher score indicates greater adherence to diabetes management.
Diabetes-related Hospitalizations
Time frame: 8 months post-baseline
Participant report and medical record review of reported diabetes-related hospitalizations for the duration of the study period. The total number of diabetes-related emergency department visits/hospitalizations is summed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plan, Reflect, and Engage with Providers for Diabetes Care in people with Type 1 Diabetes Mellitus, 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 2 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 26 May 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 5 May 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?
Hemoglobin A1c (time frame: 8 months post-baseline). The study lists 4 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 26 May 2026.