Diabetes Mellitus, Type 1NCT06931275
Best Practice Advisories to Reduce Inequities in Technology Use for People With Type 1 Diabetes
A study testing EMR-based BPA model in people with Diabetes Mellitus, Type 1, run by T1D Exchange, United States at 2 sites in United States.
Trial summary
The overall goal of the study is to create a standardized, stakeholder-informed system within EMRs, that will enable an equitable and regular prescription and documentation of advanced diabetes technologies. This will reduce racial disparities and generate an understanding of the reasons behind prescription decisions. Read more about this study
- Who is it for?
- Ages 2 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- EMR-based BPA model
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,178 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2024to 30 Jul 2027
- 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 2 to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- non-Hispanic Black and Hispanic individuals
Who cannot join
- PwT1D with evidence of use of AID at baseline
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
T1D Exchange
Boston, Massachusetts, 02110
Osagie Ebekozien, MPH, MD, 857-205-2388, oebekozien@t1dexchange.org
Trevon Wright, MHA, 617-892-7564, twright@t1dexchange.org
- Not yet recruiting
T1D Exchange
Boston, Massachusetts, 02111
Osagie Ebekozien, MD, 8572052388, oebekozien@t1dexchange.org
Trevon Wright, MHA, 2569497029, twright@t1dexchange.org
About this study
Official title: Implementing Best Practice Advisories to Reduce Inequities in Technology Use for People With Type 1 Diabetes
The overall goal of the study is to create a standardized, stakeholder-informed system within EMRs, that will enable an equitable and regular prescription and documentation of advanced diabetes technologies. This will reduce racial disparities and generate an understanding of the reasons behind prescription decisions.
The study will highlight the development and implementation an EMR-based Best Practice Advisory (BPA).
The study will answer whether the EMR-based BPA can effectively reduce disparities. Additionally, it will explore why providers may not prescribe advanced diabetes technologies.
Patients will also be surveyed to understand their perspectives on developing the EMR-based BPA.
Read the detailed description
For the proposed study we intend to implement an automatically delivered center decision support system provided at the time and location of the decision making along with actionable recommendations and computer based actionable recommendations. The provider will be required to opt out if not prescribing ADT and to provide a reason for not prescribing in order to advance on the EMR screen (Kawamoto et al, 2015).
Project Objectives Aim 1: To develop and implement an EMR-based BPA using stakeholder feedback to standardize the approach for prescribing and documentation of advanced diabetes technologies (ADT) (CGM, insulin pump, AID) among adult and pediatric PwT1D.
Aim 2: To determine the effectiveness of an EMR-based BPA in reducing racial inequities in ADT.
Primary Objective: To compare the proportion of non-white (non-Hispanic Black and Hispanic) PwT1D with progression in ADT use (CGM, insulin pump, AID) at 6 centers in the T1DX-QI (3 pediatric and 3 adult centers) where the BPA intervention is implemented with matched control non-white PwT1D at T1DX-QI centers not receiving the intervention over a 12-month period, adjusting for baseline level of ADT use and other confounders.
Secondary Objective: To assess the difference in ADT use between White and non-white (non-Hispanic Black and Hispanic) PwT1D receiving care at the intervention centers compared with the racial difference in ADT use in matched control PwT1D.
Aim 3: To explore the reasons identified for providers decision to not prescribe ADT and whether they were patient or provider led, and the association between the reason provided and the patient's race/ethnicity.
Methodology Overview Focus group discussions and structured interviews will be conducted among adult and pediatric endocrine providers based on the Agency for Healthcare Research and Quality (AHRQ) "Five Rights" (Flores et al, 2019) which engenders effective clinical decision support. Also other guiding frameworks such as the T1d Exchange Health Equity Framework (Ebekozien et al, 2019) will guide this process. The BPA as well as the approach to be followed for the documenting discussions between the provider and patients will be refined by the results of the qualitative study.
Using a non-randomized matched-pair intervention design, we will compare ADT use following a BPA intervention among non-Hispanic Black and Hispanic PwT1D receiving care at 6 T1DX-QI centers with matched control non-Hispanic Black and Hispanic PwT1D receiving care at a non-intervention center over a 12-month period.
Six T1DX-QI centers that are data mapped to the T1DX-QI database by study initiation will be selected for the intervention centers. There will be four additional centers as possible back-up if one or more of the 6 anticipated centers are not able to participate. Matched "control" PwT1D will also be selected from centers with mapped data.
Primary Outcome Definition: Primary outcome: Progression in ADT use (as documented in EMR) during the 12-month study period. The primary outcome would be defined as positive for an individual if any of the following occurs:
- No CGM à Any CGM
- MDI à Insulin pump
- No AID à AID
Based on this definition, a PwT1D in any of the following technology transition states would be considered as meeting the primary endpoint:
- MDI/smartpen + no CGM begins using CGM
- MDI/smartpen + CGM begins using insulin pump
- Insulin pump + no CGM begins using CGM
- Insulin pump + CGM (without AID) begins using AID
Data Analysis for Aim2 Primary: Progression in ADT use in the intervention group compared with matched-pair controls adjusting for number of encounters, correlation of matched pairs, and random center effects.
Secondary: Analysis will mimic the primary analysis for adjustment of confounders.
- Progression in AID use in the intervention group compared with matched pair controls
- Progression in CGM use in the intervention group compared with matched pair controls
- Progression in Insulin Pump use in the intervention group compared with matched pair controls
- Change in the proportional difference in CGM use between white and non-white individuals (non-Hispanic black and/or Hispanic) in the intervention group compared with matched pair controls.
- Change in the proportional difference in insulin Pump use between white and non-white individuals (non-Hispanic black and/or Hispanic) in the intervention group compared with matched pair controls
- Change in HbA1c (lab result closest to end date of period) from baseline in the intervention group compared with matched pair controls Exploratory: Analysis will mimic the primary analysis for adjustment of confounders.
- Change in proportion of sustained ADT Use in in the intervention group compared with matched pair controls. Sustained use defined as at least two consecutive EMR records with ADT use documented during the post period.
We will explore if the reasons technologies are not recommended/accepted differ by race and other factors. This aim is exploratory, and the extent of the analysis will ultimately depend on information collected as part of the BPA developed during Aim 1. If patient race is associated with differences in rates of technology prescribing/use, these findings will inform further interventions to address the contributing causes.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- EMR-based BPA model, Placebo (EMR-based without BPA model)
- Keywords
- Advanced Diabetes Technologies,, Automated Insulin Delivery, Best Practice Advisories, Continuous Glucose Monitoring.
- 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.
EMR-based BPA modelOther
Advanced Diabetes Technologies including AIDs, insulin pumps and CGMs will be prescribed to patients after an EMR-based BPA implementation at six centers.
Placebo (EMR-based without BPA model)Behavioural
Advanced Diabetes Technologies including AIDs, insulin pumps and CGMs will be prescribed to patients after an EMR-based system without BPA at the implementation at six centers.
| Study group | Role | What they receive |
|---|---|---|
| ADT use following Best Practice Advisory among non- Hispanic Black and Hispanic Patients with T1D | Experimental | ADT use following a BPA intervention among non-Hispanic Black and Hispanic PwT1D receiving care at 6 T1DX-QI centers will be assessed. The EMR-based BPA will be designed to recommend ADT prescription to patients not already using some type of ADT using a rule-based algorithm. ADT will include CGM, insulin pumps, and AID systems. We will work with each of the 6 centers to implement the BPA as part of the Epic EMR. The function will generate a BPA if patient is not utilizing a CGM or pump/AID. If the patient is not on a CGM, pump or AID system (if already using CGM and pump), the BPA will suggest discussing and/or prescribing CGM (or pump/AID) to the provider. The provider will answer in the affirmative or say, "not discussed" or "patient declined." If the provider chooses to opt out of prescribing, they will be forced to provide a reason for not prescribing to advance the screen. Providers in each intervention center will be trained on the BPA process prior to implementation. Receives: Other: EMR-based BPA model |
| ADT use among non- Hispanic Black and Hispanic Patients with T1D | Placebo comparator | The arm will comprise of a matched control non-Hispanic Black and Hispanic PwT1D receiving care at a center over a 12-month period. Participants will be matched on the basis of Age categories, biological sex, Insurance status, Area deprivation index, Baseline Technology use, Duration of T1D bins, and Baseline HbA1c. Receives: Behavioral: Placebo (EMR-based without BPA model) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of Advanced Diabetes Technology use
Defined as positive for an individual if: • MDI/smartpen + no CGM begins using CGM
- MDI/smartpen + CGM begins using insulin pump
- Insulin pump + no CGM begins using CGM
- Insulin pump + CGM (without AID) begins using AID
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start13 Aug 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- T1D Exchange, United States
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osagie Ebekozien, T1D Exchange, United States
- Investigators
- Osagie Ebekozien, Principal investigator, T1DExchangeNestoras Mathioudakis, Study director, Johns Hopkins UniversityRisa Wolf, Study director, Johns Hopkins Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931275
- Sponsor's protocol ID
- 98752815
- Status last verified
- Jun 2024
- First submitted
- 9 Sep 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no Individual Participant data collection.
Publications
Ebekozien O, Mungmode A, Buckingham D, Greenfield M, Talib R, Steenkamp D, Haw JS, Odugbesan O, Harris M, Mathias P, Dickinson JK, Agarwal S. Achieving Equity in Diabetes Research: Borrowing From the Field of Quality Improvement Using a Practical Framework and Improvement Tools. Diabetes Spectr. 2022 Summer;35(3):304-312. doi: 10.2337/dsi22-0002. Epub 2022 Aug 15.
PubMed 36072814Kawamoto K, Houlihan CA, Balas EA, Lobach DF. Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ. 2005 Apr 2;330(7494):765. doi: 10.1136/bmj.38398.500764.8F. Epub 2005 Mar 14.
PubMed 15767266Flores EJ, Jue JJ, Giradi G, Schoelles K, Mull NK, Umscheid CA. AHRQ EPC Series on Improving Translation of Evidence: Use of a Clinical Pathway for C. Difficile Treatment to Facilitate the Translation of Research Findings into Practice. Jt Comm J Qual Patient Saf. 2019 Dec;45(12):822-828. doi: 10.1016/j.jcjq.2019.10.002. Epub 2019 Oct 28.
PubMed 31672660Mathioudakis N, Wolf R, Choudhary A, Davis G, Gallagher MP, Gupta M, Kamboj M, Rioles N, Ospelt E, Thapa S, Weinstock RS, Wright T, Ebekozien O. Implementation and Evaluation of a Best Practice Advisory to Reduce Inequities in Technology Use for People With Type 1 Diabetes: Protocol for a Mixed Methods, Nonrandomized Controlled Trial. JMIR Res Protoc. 2025 May 28;14:e71038. doi: 10.2196/71038.
PubMed 40434817
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Best Practice Advisories to Reduce Inequities in Technology Use for People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06931275
- Acronym / sponsor ID
- 98752815
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Advanced Diabetes Technologies,, Automated Insulin Delivery, Best Practice Advisories, Continuous Glucose Monitoring.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,178 participants (estimated)
- Lead sponsor
- T1D Exchange, United StatesUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 17 Apr 2025 (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 overall goal of the study is to create a standardized, stakeholder-informed system within EMRs, that will enable an equitable and regular prescription and documentation of advanced diabetes technologies. This will reduce racial disparities and generate an understanding of the reasons behind prescription decisions.
The study will highlight the development and implementation an EMR-based Best Practice Advisory (BPA).
The study will answer whether the EMR-based BPA can effectively reduce disparities. Additionally, it will explore why providers may not prescribe advanced diabetes technologies.
Patients will also be surveyed to understand their perspectives on developing the EMR-based BPA.
Detailed description
For the proposed study we intend to implement an automatically delivered center decision support system provided at the time and location of the decision making along with actionable recommendations and computer based actionable recommendations. The provider will be required to opt out if not prescribing ADT and to provide a reason for not prescribing in order to advance on the EMR screen (Kawamoto et al, 2015).
Project Objectives Aim 1: To develop and implement an EMR-based BPA using stakeholder feedback to standardize the approach for prescribing and documentation of advanced diabetes technologies (ADT) (CGM, insulin pump, AID) among adult and pediatric PwT1D.
Aim 2: To determine the effectiveness of an EMR-based BPA in reducing racial inequities in ADT.
Primary Objective: To compare the proportion of non-white (non-Hispanic Black and Hispanic) PwT1D with progression in ADT use (CGM, insulin pump, AID) at 6 centers in the T1DX-QI (3 pediatric and 3 adult centers) where the BPA intervention is implemented with matched control non-white PwT1D at T1DX-QI centers not receiving the intervention over a 12-month period, adjusting for baseline level of ADT use and other confounders.
Secondary Objective: To assess the difference in ADT use between White and non-white (non-Hispanic Black and Hispanic) PwT1D receiving care at the intervention centers compared with the racial difference in ADT use in matched control PwT1D.
Aim 3: To explore the reasons identified for providers decision to not prescribe ADT and whether they were patient or provider led, and the association between the reason provided and the patient's race/ethnicity.
Methodology Overview Focus group discussions and structured interviews will be conducted among adult and pediatric endocrine providers based on the Agency for Healthcare Research and Quality (AHRQ) "Five Rights" (Flores et al, 2019) which engenders effective clinical decision support. Also other guiding frameworks such as the T1d Exchange Health Equity Framework (Ebekozien et al, 2019) will guide this process. The BPA as well as the approach to be followed for the documenting discussions between the provider and patients will be refined by the results of the qualitative study.
Using a non-randomized matched-pair intervention design, we will compare ADT use following a BPA intervention among non-Hispanic Black and Hispanic PwT1D receiving care at 6 T1DX-QI centers with matched control non-Hispanic Black and Hispanic PwT1D receiving care at a non-intervention center over a 12-month period.
Six T1DX-QI centers that are data mapped to the T1DX-QI database by study initiation will be selected for the intervention centers. There will be four additional centers as possible back-up if one or more of the 6 anticipated centers are not able to participate. Matched "control" PwT1D will also be selected from centers with mapped data.
Primary Outcome Definition: Primary outcome: Progression in ADT use (as documented in EMR) during the 12-month study period. The primary outcome would be defined as positive for an individual if any of the following occurs:
- No CGM à Any CGM
- MDI à Insulin pump
- No AID à AID
Based on this definition, a PwT1D in any of the following technology transition states would be considered as meeting the primary endpoint:
- MDI/smartpen + no CGM begins using CGM
- MDI/smartpen + CGM begins using insulin pump
- Insulin pump + no CGM begins using CGM
- Insulin pump + CGM (without AID) begins using AID
Data Analysis for Aim2 Primary: Progression in ADT use in the intervention group compared with matched-pair controls adjusting for number of encounters, correlation of matched pairs, and random center effects.
Secondary: Analysis will mimic the primary analysis for adjustment of confounders.
- Progression in AID use in the intervention group compared with matched pair controls
- Progression in CGM use in the intervention group compared with matched pair controls
- Progression in Insulin Pump use in the intervention group compared with matched pair controls
- Change in the proportional difference in CGM use between white and non-white individuals (non-Hispanic black and/or Hispanic) in the intervention group compared with matched pair controls.
- Change in the proportional difference in insulin Pump use between white and non-white individuals (non-Hispanic black and/or Hispanic) in the intervention group compared with matched pair controls
- Change in HbA1c (lab result closest to end date of period) from baseline in the intervention group compared with matched pair controls Exploratory: Analysis will mimic the primary analysis for adjustment of confounders.
- Change in proportion of sustained ADT Use in in the intervention group compared with matched pair controls. Sustained use defined as at least two consecutive EMR records with ADT use documented during the post period.
We will explore if the reasons technologies are not recommended/accepted differ by race and other factors. This aim is exploratory, and the extent of the analysis will ultimately depend on information collected as part of the BPA developed during Aim 1. If patient race is associated with differences in rates of technology prescribing/use, these findings will inform further interventions to address the contributing causes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT use following Best Practice Advisory among non- Hispanic Black and Hispanic Patients with T1D | Experimental | Other: EMR-based BPA modelADT use following a BPA intervention among non-Hispanic Black and Hispanic PwT1D receiving care at 6 T1DX-QI centers will be assessed. The EMR-based BPA will be designed to recommend ADT prescription to patients not already using some type of ADT using a rule-based algorithm. ADT will include CGM, insulin pumps, and AID systems. We will work with each of the 6 centers to implement the BPA as part of the Epic EMR. The function will generate a BPA if patient is not utilizing a CGM or pump/AID. If the patient is not on a CGM, pump or AID system (if already using CGM and pump), the BPA will suggest discussing and/or prescribing CGM (or pump/AID) to the provider. The provider will answer in the affirmative or say, "not discussed" or "patient declined." If the provider chooses to opt out of prescribing, they will be forced to provide a reason for not prescribing to advance the screen. Providers in each intervention center will be trained on the BPA process prior to implementation. |
| ADT use among non- Hispanic Black and Hispanic Patients with T1D | Placebo comparator | Behavioral: Placebo (EMR-based without BPA model)The arm will comprise of a matched control non-Hispanic Black and Hispanic PwT1D receiving care at a center over a 12-month period. Participants will be matched on the basis of Age categories, biological sex, Insurance status, Area deprivation index, Baseline Technology use, Duration of T1D bins, and Baseline HbA1c. |
Who may qualify
- Ages
- 2 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- non-Hispanic Black and Hispanic individuals
Key exclusion criteria (1 listed)
- PwT1D with evidence of use of AID at baseline
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 |
|---|---|---|
| EMR-based BPA modelAdvanced Diabetes Technologies including AIDs, insulin pumps and CGMs will be prescribed to patients after an EMR-based BPA implementation at six centers. | Other | ADT use following Best Practice Advisory among non- Hispanic Black and Hispanic Patients with T1D |
| Placebo (EMR-based without BPA model)Advanced Diabetes Technologies including AIDs, insulin pumps and CGMs will be prescribed to patients after an EMR-based system without BPA at the implementation at six centers. | Behavioural | ADT use among non- Hispanic Black and Hispanic Patients with T1D |
Primary outcome
Progression of Advanced Diabetes Technology use
Time frame: 12 months
Defined as positive for an individual if: • MDI/smartpen + no CGM begins using CGM * MDI/smartpen + CGM begins using insulin pump * Insulin pump + no CGM begins using CGM * Insulin pump + CGM (without AID) begins using AID
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 17 Apr 2025.
- Background: PubMed 36072814Ebekozien O, Mungmode A, Buckingham D, Greenfield M, Talib R, Steenkamp D, Haw JS, Odugbesan O, Harris M, Mathias P, Dickinson JK, Agarwal S. Achieving Equity in Diabetes Research: Borrowing From the Field of Quality Improvement Using a Practical Framework and Improvement Tools. Diabetes Spectr. 2022 Summer;35(3):304-312. doi: 10.2337/dsi22-0002. Epub 2022 Aug 15.
- Results publication: PubMed 15767266Kawamoto K, Houlihan CA, Balas EA, Lobach DF. Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ. 2005 Apr 2;330(7494):765. doi: 10.1136/bmj.38398.500764.8F. Epub 2005 Mar 14.
- Results publication: PubMed 31672660Flores EJ, Jue JJ, Giradi G, Schoelles K, Mull NK, Umscheid CA. AHRQ EPC Series on Improving Translation of Evidence: Use of a Clinical Pathway for C. Difficile Treatment to Facilitate the Translation of Research Findings into Practice. Jt Comm J Qual Patient Saf. 2019 Dec;45(12):822-828. doi: 10.1016/j.jcjq.2019.10.002. Epub 2019 Oct 28.
- Derived from this study: PubMed 40434817Mathioudakis N, Wolf R, Choudhary A, Davis G, Gallagher MP, Gupta M, Kamboj M, Rioles N, Ospelt E, Thapa S, Weinstock RS, Wright T, Ebekozien O. Implementation and Evaluation of a Best Practice Advisory to Reduce Inequities in Technology Use for People With Type 1 Diabetes: Protocol for a Mixed Methods, Nonrandomized Controlled Trial. JMIR Res Protoc. 2025 May 28;14:e71038. doi: 10.2196/71038.
- Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to successLink provided by the sponsor.
- AHRQ EPC Series on Improving Translation of Evidence: Use of a Clinical Pathway for C. Difficile Treatment to Facilitate the Translation of Research Findings into PracticeLink provided by the sponsor.
- Achieving Equity in Diabetes Research: Borrowing From the Field of Quality Improvement Using a Practical Framework and Improvement ToolsLink provided by the sponsor.
- Individual participant dataSharing planned: No. There will be no Individual Participant data collection.
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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.
Osagie Ebekozien principal investigator
T1DExchange
Nestoras Mathioudakis study director
Johns Hopkins University
Risa Wolf study director
Johns Hopkins Pediatrics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMR-based BPA model in people with Diabetes Mellitus, Type 1, run by T1D Exchange, United States at 2 sites 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 1 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 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Osagie Ebekozien, MD (857-205-2388, oebekozein@t1dexchange.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of Advanced Diabetes Technology use (time frame: 12 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 NCT06931275, which also lists 4 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 17 Apr 2025.