Diabetes Mellitus, Type 1IMPACT-T1DNCT06229236
Assessing Effectiveness of a Diabetes Navigator in Increasing Progression of Advanced Diabetes Technologies
A study testing Diabetes Navigator in people with Diabetes Mellitus, Type 1, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this randomized control trial is to determine if the support of a Diabetes Navigator is more effective than standard care in improving uptake and use of advanced diabetes technology among patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Diabetes Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to 26 Sep 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 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female aged 5 to 75 years.
- Diagnosis of type 1 diabetes
- Patient of Johns Hopkins Medicine adult or pediatric diabetes clinics
- Not using or not optimally using diabetes technology.
- Planned Diabetes technology intensification by diabetes provider.
- If already on diabetes technology - must be using the specific device for a minimum of 14 days.
Who cannot join
- Optimally using Diabetes Technology
- Pregnancy or lactation or planned pregnancy in the next 12 months.
- Other types of diabetes (type 2 diabetes, Maturity Onset Diabetes in Youth, cystic fibrosis-related diabetes, steroid-induced diabetes, post total pancreatectomy, transplant-related diabetes)
- Active participant of any other research study that may interfere with diabetes management.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
About this study
Official title: Assessing Effectiveness of a Diabetes Navigator in Increasing Progression (Improving Uptake and/or Optimization) of Advanced Diabetes Technologies
The goal of this randomized control trial is to determine if the support of a Diabetes Navigator is more effective than standard care in improving uptake and use of advanced diabetes technology among patients with type 1 diabetes.
Read the detailed description
This study will recruit 148 individuals, 74 adults (ages 21-75) and 74 youth (ages 5-20) with type 1 diabetes. Participants will be randomized to standard care (usual diabetes care) or the intervention arm in which the participants will receive additional support from a Diabetes Navigator. Participants in the intervention group will receive assistance from a Diabetes Navigator who will help the participants address challenges in acquiring and optimally using advanced diabetes technology. The investigators will compare the group receiving Diabetes Navigator support with the standard care group to see if the additional support improves progression (increases uptake and/or optimization) in use of advanced diabetes technology and, consequently, improves glycemic control among patients.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Diabetes Navigator
- Keywords
- Continuous Glucose Monitor (CGM), Insulin Pumps, Hybrid Closed Loop (HCL), Diabetes Navigator, Diabetes Navigator Toolkit, Advanced Diabetes Technology (ADT)
- 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 NavigatorBehavioural
Participants in the Diabetes Navigator (DN) arm will receive support from a trained navigator to help them improve progression (improving use/optimization) in use of advanced diabetes technology. The Diabetes Navigator will engage with participants immediately after randomization, throughout the duration of study, using a predefined toolkit, educational resources and interventions to assist them in optimizing use of advanced diabetes technology.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Navigator | Experimental | Support and guidance of Diabetes Navigator in addition to standard care Receives: Behavioral: Diabetes Navigator |
| Standard of Care | No intervention | Standard care provided by the healthcare staff during routine diabetes clinic visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Whose Diabetes Technology Utilization Score (DTUS) Increases (Based on Review of Last 14 Days of CGM and Insulin Pump Data)
Participants whose DTUS increased from baseline to 3 months as a binary outcome (yes/no question)
Measured: From baseline to 3 months
Secondary outcomes (5)
Participants Whose Diabetes Technology Utilization Score (DTUS) Increases (90 Days of Data)
Participants whose DTUS increased from baseline to 3 months as a binary outcome (yes/no question). Using data from baseline to 90 days.
Measured: From baseline to 3 months
Participants Whose Diabetes Technology Utilization Score (DTUS) Stays the Same or Increased at 6 Months Among Those Whose DTUS Increased at 3 Months
Participants whose Diabetes Technology Utilization Score (DTUS) stays the same or increased at 6 months among those whose DTUS increased at 3 months measured at 6 months as a binary outcome (yes/no question).
Measured: From 3 months to 6 months
Participants Whose Diabetes Technology Use Score (DTUS) Increases (Based on Review of Last 14 Days of CGM and Insulin Pump Data) at 6 Months
Participants whose diabetes technology use score (DTUS) increases from baseline to 6 months measured as a binary (yes/no) variable.
Measured: From baseline to 6 months
Changes in Continuous Glucose Monitor (CGM) Percent Time Active
Change in the CGM percentage time active from baseline to 3 months using 14 days of CGM data at each time-point
Measured: From baseline to 3 months
Change in Glycated Hemoglobin (HbA1c)
Change in glycated Hemoglobin levels from baseline to 6 months
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start13 Feb 2024
- Primary completion26 Aug 2025
- Study completion26 Sep 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nestoras Mathioudakis, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229236
- Sponsor's protocol ID
- IRB00398788
- Other IDs
- R01DK134955
- Acronym
- IMPACT-T1D
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2024
- Last updated
- 23 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin T, Manfredo JA, Illesca N, Abiola K, Hwang N, Salsberg S, Akhtar Y, Mathioudakis N, Brown EA, Wolf RM. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study. Diabetes Technol Ther. 2023 Jan;25(1):13-19. doi: 10.1089/dia.2022.0347. Epub 2022 Nov 7.
PubMed 36223197Kanbour S, Jones M, Abusamaan MS, Nass C, Everett E, Wolf RM, Sidhaye A, Mathioudakis N. Racial Disparities in Access and Use of Diabetes Technology Among Adult Patients With Type 1 Diabetes in a U.S. Academic Medical Center. Diabetes Care. 2023 Jan 1;46(1):56-64. doi: 10.2337/dc22-1055.
PubMed 36378855
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Effectiveness of a Diabetes Navigator in Increasing Progression (Improving Uptake and/or Optimization) of Advanced Diabetes Technologies
- ClinicalTrials.gov ID
- NCT06229236
- Acronym / sponsor ID
- IMPACT-T1D / IRB00398788
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Continuous Glucose Monitor (CGM), Insulin Pumps, Hybrid Closed Loop (HCL), Diabetes Navigator, Diabetes Navigator Toolkit, Advanced Diabetes Technology (ADT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Posted 23 Sep 2026
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 control trial is to determine if the support of a Diabetes Navigator is more effective than standard care in improving uptake and use of advanced diabetes technology among patients with type 1 diabetes.
Detailed description
This study will recruit 148 individuals, 74 adults (ages 21-75) and 74 youth (ages 5-20) with type 1 diabetes. Participants will be randomized to standard care (usual diabetes care) or the intervention arm in which the participants will receive additional support from a Diabetes Navigator. Participants in the intervention group will receive assistance from a Diabetes Navigator who will help the participants address challenges in acquiring and optimally using advanced diabetes technology. The investigators will compare the group receiving Diabetes Navigator support with the standard care group to see if the additional support improves progression (increases uptake and/or optimization) in use of advanced diabetes technology and, consequently, improves glycemic control among patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Navigator | Experimental | Behavioral: Diabetes NavigatorSupport and guidance of Diabetes Navigator in addition to standard care |
| Standard of Care | No intervention | –Standard care provided by the healthcare staff during routine diabetes clinic visits. |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged 5 to 75 years.
- Diagnosis of type 1 diabetes
- Patient of Johns Hopkins Medicine adult or pediatric diabetes clinics
- Not using or not optimally using diabetes technology.
- Planned Diabetes technology intensification by diabetes provider.
Key exclusion criteria (4 listed)
- Optimally using Diabetes Technology
- Pregnancy or lactation or planned pregnancy in the next 12 months.
- Other types of diabetes (type 2 diabetes, Maturity Onset Diabetes in Youth, cystic fibrosis-related diabetes, steroid-induced diabetes, post total pancreatectomy, transplant-related diabetes)
- Active participant of any other research study that may interfere with diabetes management.
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 NavigatorParticipants in the Diabetes Navigator (DN) arm will receive support from a trained navigator to help them improve progression (improving use/optimization) in use of advanced diabetes technology. The Diabetes Navigator will engage with participants immediately after randomization, throughout the duration of study, using a predefined toolkit, educational resources and interventions to assist them in optimizing use of advanced diabetes technology. | Behavioural | Diabetes Navigator |
Primary outcome
Participants Whose Diabetes Technology Utilization Score (DTUS) Increases (Based on Review of Last 14 Days of CGM and Insulin Pump Data)
Time frame: From baseline to 3 months
Participants whose DTUS increased from baseline to 3 months as a binary outcome (yes/no question)
5 secondary outcomes
Participants Whose Diabetes Technology Utilization Score (DTUS) Increases (90 Days of Data)
Time frame: From baseline to 3 months
Participants Whose Diabetes Technology Utilization Score (DTUS) Stays the Same or Increased at 6 Months Among Those Whose DTUS Increased at 3 Months
Time frame: From 3 months to 6 months
Participants Whose Diabetes Technology Use Score (DTUS) Increases (Based on Review of Last 14 Days of CGM and Insulin Pump Data) at 6 Months
Time frame: From baseline to 6 months
Changes in Continuous Glucose Monitor (CGM) Percent Time Active
Time frame: From baseline to 3 months
Change in Glycated Hemoglobin (HbA1c)
Time frame: From baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36223197Lin T, Manfredo JA, Illesca N, Abiola K, Hwang N, Salsberg S, Akhtar Y, Mathioudakis N, Brown EA, Wolf RM. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study. Diabetes Technol Ther. 2023 Jan;25(1):13-19. doi: 10.1089/dia.2022.0347. Epub 2022 Nov 7.
- Background: PubMed 36378855Kanbour S, Jones M, Abusamaan MS, Nass C, Everett E, Wolf RM, Sidhaye A, Mathioudakis N. Racial Disparities in Access and Use of Diabetes Technology Among Adult Patients With Type 1 Diabetes in a U.S. Academic Medical Center. Diabetes Care. 2023 Jan 1;46(1):56-64. doi: 10.2337/dc22-1055.
- 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.
Nestoras Mathioudakis, MD principal investigator
Johns Hopkins University
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 Navigator in people with Diabetes Mellitus, Type 1, run by Johns Hopkins University 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 6 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 23 Sep 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 23 Sep 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?
Participants Whose Diabetes Technology Utilization Score (DTUS) Increases (Based on Review of Last 14 Days of CGM and Insulin Pump Data) (time frame: From baseline to 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 NCT06229236, which also lists 2 linked publications.
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 23 Sep 2026.