Type 1 DiabetesTeKnO T1DNCT05300022
Technology Knowledge Optimization in Type 1 Diabetes (TeKnO T1D): Parents
A study testing TeKnO T1D: Parents in people with Type 1 Diabetes, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study aims to identify the unmet psychoeducational needs of parents of children 8-12 years of age using insulin pump and CGM for pediatric T1D management and to leverage that information to develop an innovative app-based psychoeducational intervention to optimize use of these technologies and improve T1D… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- TeKnO T1D: Parents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- child 8-12 years of age with a diagnosis of T1D ≥ 6 months
- currently using insulin pump( IP) and CGM ≥ 1 month [including Hybrid Closed Loop (HCL) systems]
- participation of primary diabetes caregiver
- English fluency
- mean A1c >7.5% over the past 6 months (Aim 3 only)
Who cannot join
- major illnesses other than T1D in the child
- significant cognitive limitations or major psychiatric disorders in the child or parent
- the use of medications other than insulin to control blood glucose levels.
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
This study aims to identify the unmet psychoeducational needs of parents of children 8-12 years of age using insulin pump and CGM for pediatric T1D management and to leverage that information to develop an innovative app-based psychoeducational intervention to optimize use of these technologies and improve T1D outcomes.
Read the detailed description
Despite increased use of insulin pumps and continuous glucose monitors (CGM) for pediatric type 1 diabetes (T1D) management and research studies showing benefits from the use of these devices, real-world glycemic control among youth with T1D has worsened in recent years. Although greater youth and parental diabetes knowledge is associated with better glycemic control, education alone is not sufficient to bring about the behavioral changes needed to improve outcomes in T1D. Psychoeducation recognizes the need to blend educational and behavioral approaches, including problem-solving and goal-setting, to support parents in developing optimal T1D management approaches. There are currently a lack of effective standardized tools to support patients and families in developing the knowledge and behavioral strategies needed to optimize the use of diabetes technologies. The development of innovative family-centered psychoeducational tools addressing both behavior and knowledge will help to realize the full potential of diabetes technologies to improve glycemic control and quality of life while ultimately preventing or delaying the development of both acute and long-term complications of T1D.
Interviews with parent-child dyads and diabetes clinicians will be used to identify the unmet parental psychoeducational needs regarding insulin pumps and CGM. These results will inform the use of instructional design to adapt an existing app-delivered diabetes technology curriculum to meet the specific needs of parents of children with T1D. Finally, the investigators will assess the feasibility and acceptability of this novel family-facing psychoeducational app-delivered intervention in a non-randomized pilot study.
- Conditions
- Type 1 Diabetes
- Being tested
- TeKnO T1D: Parents
- Keywords
- pediatric, continuous glucose monitor, insulin pump, automated insulin delivery, hybrid closed loop systems, medical education, diabetes technology
- 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.
TeKnO T1D: ParentsOther
app-delivered curriculum to provide psychoeducational education surrounding diabetes technology use
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Semi-structured Interviews | No intervention | Arm 1 will be conducted from months 0-15 and will use interviews to better understand existing challenges in diabetes technology educational practices. It is not a clinical trial, but is a crucial part of what builds to the clinical trial. |
| Arm 2: Designing an App Delivered Curriculum | Experimental | Arm 2 will be conducted from months 10-33 and will use information learned in arm 1 to develop and beta test an educational curriculum. Arm 2 also is not a clinical trial, but is a crucial part of what builds to the clinical trial. Receives: Other: TeKnO T1D: Parents |
| Arm 3: TeKnO T1D: Parents Pilot Study | Active comparator | Arm 3 will be conducted from months 30-60 and involves a pilot and feasibility study of the newly developed educational curriculum. This is the clinical trial. Receives: Other: TeKnO T1D: Parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Recruitment
Percentage of eligible patients who are approached and enroll in the study in Arm 3.
Measured: Arm 3: Months 30-60
Intervention Satisfaction
Score on a survey developed to assess satisfaction with the Technology Knowledge Optimization Type 1 Diabetes: Parents curriculum in Arm 3. Scores range from 0-100 with higher scores reflecting greater satisfaction.
Measured: Arm 3: Months 30-60
Perceived Intervention Utility
Score on a survey developed to assess the perceived utility of the Technology Knowledge Optimization Type 1 Diabetes: Parents curriculum during Arm 3. Scores range from 0-100 with higher scores reflecting greater perceived utility.
Measured: Arm 3: Months 30-60
Intervention Completion
Percentage of enrolled participants who complete the TeKnO T1D: Parents Curriculum in Arm 3.
Measured: Arm 3: Months 30-60
Intervention Retention
Percentage of enrolled participants who complete the entire intervention for Arm 3.
Measured: Arm 3: Months 30-60
Secondary outcomes (26)
Hemoglobin A1c
Hemoglobin A1c will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
CGM Mean Sensor Glucose
CGM mean sensor glucose will be assessed prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: months 0-60
CGM Glucose Management Indicator
The Glucose Management Indicator will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
CGM Coefficient of Variation of the Mean
The Coefficient of Variation of the Mean will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. .
Measured: Arm 3: Months 30-60
CGM Time in Range (70-180 mg/dL)
CGM Time in Range (70-180 mg/dL) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
CGM Time Below Range (<70 mg/dL)
CGM Time Below Range (<70 mg/dL) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
CGM Time Above Range (<180 mg/dL)
CGM Time Above Range (<180 mg/dL) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
CGM Wear Time
The percentage of CGM wear time will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
Total Daily Insulin Dose
Total Daily Insulin Dose will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
Total Daily Basal Insulin Dose
Total Daily Basal Insulin Dose will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
Percent Basal Insulin Dose
The percentage of the total daily insulin derived from basal insulin (basal insulin/ total daily insulin dose) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
Number of boluses per day
The number of boluses per day will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
Carbohydrate intake logged on insulin pump
The number of grams of carbohydrate intake logged on insulin pump will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
Episodes of Severe Hypoglycemia
The number of episodes of severe hypoglycemia will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
Emergency Department Visits
The number of diabetes-related emergency department visits will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
Hospital Admissions
The number of diabetes-related hospital admissions will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
Episodes of Diabetic Ketoacidosis
The number of episodes of diabetic ketoacidosis will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Measured: Arm 3: Months 30-60
Parent Diabetes-Specific Quality of Life
The Type 1 Diabetes and Life (T1DAL) is a validated survey assessing diabetes-specific quality of life. T1DAL will be will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater quality of life.
Measured: Arm 3: Months 30-60
Parent Emotional Distress Related to T1D
Parents of Children (P-PAID) is a validated survey assessing emotional distress related to T1D. P-PAID will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 15 to 96 with higher scores reflecting greater emotional distress.
Measured: Arm 3: Months 30-60
Parent Diabetes Self-Management
The Diabetes Management Questionnaire (DMQ) is a validated survey assessing diabetes self-management. The DMQ will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater adherence to diabetes management.
Measured: Arm 3: Months 30-60
Parent Perceived CGM Benefits and Burdens
CGM Benefits and Burdens scale is a validated survey exploring perceived benefits and burdens of CGM use. CGM Benefits and Burdens will be completed prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scoring of the CGM Benefits subscale ranges from 1 to 40 with higher scores reflecting greater perceived benefits. Scoring of the CGM Burdens subscale ranges from 1 to 40 with higher scores reflecting less perceived burden.
Measured: months 0-60
Parent Diabetes Technology Knowledge
A survey assessing diabetes technology knowledge will be developed. This survey will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater knowledge.
Measured: Arm 3: Months 30-60
Child Diabetes-Specific Quality of Life
The Type 1 Diabetes and Life (T1DAL) is a validated survey assessing diabetes-specific quality of life. T1DAL will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater quality of life.
Measured: Arm 3: Months 30-60
Child Emotional Distress Related to T1D
Problem Areas in Diabetes- Child Version (PAID-C) is a validated survey assessing emotional distress related to T1D. PAID-C will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion). Scores range from 11 to 84 with higher scores reflecting greater emotional distress.
Measured: Arm 3: Months 30-60
Child Diabetes Self-Management
The Diabetes Management Questionnaire (DMQ) is a validated survey assessing diabetes self-management. The DMQ will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater adherence to diabetes management.
Measured: Arm 3: Months 30-60
Child Perceived CGM Benefits and Burdens
CGM Benefits and Burdens scale is a validated survey exploring perceived benefits and burdens of CGM use. CGM Benefits and Burdens will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scoring of the CGM Benefits subscale ranges from 1 to 40 with higher scores reflecting greater perceived benefits. Scoring of the CGM Burdens subscale ranges from 1 to 40 with higher scores reflecting less perceived burden.
Measured: Arm 3: Months 30-60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start15 Aug 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Why it stopped: Investigator left the institution and is relinquishing the award supporting this study. The study will not launch.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brynn E Marks, MD, MSHPEd, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300022
- Sponsor's protocol ID
- 22-019791
- Other IDs
- K23DK129827
- Acronym
- TeKnO T1D
- Status last verified
- Oct 2025
- First submitted
- 18 Dec 2021
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Knowledge Optimization in Type 1 Diabetes (TeKnO T1D): Parents
- ClinicalTrials.gov ID
- NCT05300022
- Acronym / sponsor ID
- TeKnO T1D / 22-019791
- Conditions
- Type 1 Diabetes
- Keywords
- pediatric, continuous glucose monitor, insulin pump, automated insulin delivery, hybrid closed loop systems, medical education, diabetes technology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left the institution and is relinquishing the award supporting this study. The study will not launch.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 29 Mar 2022 (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.
This study aims to identify the unmet psychoeducational needs of parents of children 8-12 years of age using insulin pump and CGM for pediatric T1D management and to leverage that information to develop an innovative app-based psychoeducational intervention to optimize use of these technologies and improve T1D outcomes.
Detailed description
Despite increased use of insulin pumps and continuous glucose monitors (CGM) for pediatric type 1 diabetes (T1D) management and research studies showing benefits from the use of these devices, real-world glycemic control among youth with T1D has worsened in recent years. Although greater youth and parental diabetes knowledge is associated with better glycemic control, education alone is not sufficient to bring about the behavioral changes needed to improve outcomes in T1D. Psychoeducation recognizes the need to blend educational and behavioral approaches, including problem-solving and goal-setting, to support parents in developing optimal T1D management approaches. There are currently a lack of effective standardized tools to support patients and families in developing the knowledge and behavioral strategies needed to optimize the use of diabetes technologies. The development of innovative family-centered psychoeducational tools addressing both behavior and knowledge will help to realize the full potential of diabetes technologies to improve glycemic control and quality of life while ultimately preventing or delaying the development of both acute and long-term complications of T1D.
Interviews with parent-child dyads and diabetes clinicians will be used to identify the unmet parental psychoeducational needs regarding insulin pumps and CGM. These results will inform the use of instructional design to adapt an existing app-delivered diabetes technology curriculum to meet the specific needs of parents of children with T1D. Finally, the investigators will assess the feasibility and acceptability of this novel family-facing psychoeducational app-delivered intervention in a non-randomized pilot study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Semi-structured Interviews | No intervention | –Arm 1 will be conducted from months 0-15 and will use interviews to better understand existing challenges in diabetes technology educational practices. It is not a clinical trial, but is a crucial part of what builds to the clinical trial. |
| Arm 2: Designing an App Delivered Curriculum | Experimental | Other: TeKnO T1D: ParentsArm 2 will be conducted from months 10-33 and will use information learned in arm 1 to develop and beta test an educational curriculum. Arm 2 also is not a clinical trial, but is a crucial part of what builds to the clinical trial. |
| Arm 3: TeKnO T1D: Parents Pilot Study | Active comparator | Other: TeKnO T1D: ParentsArm 3 will be conducted from months 30-60 and involves a pilot and feasibility study of the newly developed educational curriculum. This is the clinical trial. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- child 8-12 years of age with a diagnosis of T1D ≥ 6 months
- currently using insulin pump( IP) and CGM ≥ 1 month [including Hybrid Closed Loop (HCL) systems]
- participation of primary diabetes caregiver
- English fluency
- mean A1c >7.5% over the past 6 months (Aim 3 only)
Key exclusion criteria (3 listed)
- major illnesses other than T1D in the child
- significant cognitive limitations or major psychiatric disorders in the child or parent
- the use of medications other than insulin to control blood glucose levels.
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 |
|---|---|---|
| TeKnO T1D: Parentsapp-delivered curriculum to provide psychoeducational education surrounding diabetes technology use | Other | Arm 2: Designing an App Delivered Curriculum, Arm 3: TeKnO T1D: Parents Pilot Study |
Primary outcome
Study Recruitment
Time frame: Arm 3: Months 30-60
Percentage of eligible patients who are approached and enroll in the study in Arm 3.
Intervention Satisfaction
Time frame: Arm 3: Months 30-60
Score on a survey developed to assess satisfaction with the Technology Knowledge Optimization Type 1 Diabetes: Parents curriculum in Arm 3. Scores range from 0-100 with higher scores reflecting greater satisfaction.
Perceived Intervention Utility
Time frame: Arm 3: Months 30-60
Score on a survey developed to assess the perceived utility of the Technology Knowledge Optimization Type 1 Diabetes: Parents curriculum during Arm 3. Scores range from 0-100 with higher scores reflecting greater perceived utility.
Intervention Completion
Time frame: Arm 3: Months 30-60
Percentage of enrolled participants who complete the TeKnO T1D: Parents Curriculum in Arm 3.
Intervention Retention
Time frame: Arm 3: Months 30-60
Percentage of enrolled participants who complete the entire intervention for Arm 3.
26 secondary outcomes
Hemoglobin A1c
Time frame: Arm 3: Months 30-60
CGM Mean Sensor Glucose
Time frame: months 0-60
CGM Glucose Management Indicator
Time frame: Arm 3: Months 30-60
CGM Coefficient of Variation of the Mean
Time frame: Arm 3: Months 30-60
CGM Time in Range (70-180 mg/dL)
Time frame: Arm 3: Months 30-60
CGM Time Below Range (<70 mg/dL)
Time frame: Arm 3: Months 30-60
CGM Time Above Range (<180 mg/dL)
Time frame: Arm 3: Months 30-60
CGM Wear Time
Time frame: Arm 3: Months 30-60
Total Daily Insulin Dose
Time frame: Arm 3: Months 30-60
Total Daily Basal Insulin Dose
Time frame: Arm 3: Months 30-60
Percent Basal Insulin Dose
Time frame: Arm 3: Months 30-60
Number of boluses per day
Time frame: Arm 3: Months 30-60
Carbohydrate intake logged on insulin pump
Time frame: Arm 3: Months 30-60
Episodes of Severe Hypoglycemia
Time frame: Arm 3: Months 30-60
Emergency Department Visits
Time frame: Arm 3: Months 30-60
Hospital Admissions
Time frame: Arm 3: Months 30-60
Episodes of Diabetic Ketoacidosis
Time frame: Arm 3: Months 30-60
Parent Diabetes-Specific Quality of Life
Time frame: Arm 3: Months 30-60
Parent Emotional Distress Related to T1D
Time frame: Arm 3: Months 30-60
Parent Diabetes Self-Management
Time frame: Arm 3: Months 30-60
Parent Perceived CGM Benefits and Burdens
Time frame: months 0-60
Parent Diabetes Technology Knowledge
Time frame: Arm 3: Months 30-60
Child Diabetes-Specific Quality of Life
Time frame: Arm 3: Months 30-60
Child Emotional Distress Related to T1D
Time frame: Arm 3: Months 30-60
Child Diabetes Self-Management
Time frame: Arm 3: Months 30-60
Child Perceived CGM Benefits and Burdens
Time frame: Arm 3: Months 30-60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- 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.
Brynn E Marks, MD, MSHPEd principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeKnO T1D: Parents in people with Type 1 Diabetes, run by Children's Hospital of Philadelphia 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 9 Oct 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Study Recruitment (time frame: Arm 3: Months 30-60). The study lists 5 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 9 Oct 2025.