Type 1 Diabetes MellitusNCT03324438
Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes
A study testing Home Telehealth T1D C2oYoT1-HR, Personalized Behavioral Health and Personalized Adherence Feedback in people with Type 1 Diabetes Mellitus, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal glycemic control has severe acute and long-term complications with potentially life threatening consequences. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Home Telehealth T1D C2oYoT1-HR, Personalized Behavioral Health and Personalized Adherence Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 30 Sep 2021
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- youth age 10-17 years
- A1C=9-12%
- parent(s) of child with confirmed diagnosis of T1D
- T1D duration >1 year
- parent and child agree to participate in home telehealth sessions
- ability to use telehealth equipment (i.e., computer, tablet, smartphone with internet connectivity)
Who cannot join
- developmental disability or reading disorder that prevents understanding of the intervention materials
- non-English speaking adolescents
- those with severe psychological disorders
- prescribed and taking medications that increase blood glucoses
- not seen in T1D clinic within the past year; pregnant if female; situational concerns (e.g., active custody battle)
- type 2 diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
About this study
This study addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal glycemic control has severe acute and long-term complications with potentially life threatening consequences. Lack of regular contact with T1D care providers, continued T1D nonadherence, and suboptimal behavioral and mental health functioning compromises the physical health of youth with T1D and the ability of T1D teams to provide effective treatment. If the aims of this study are achieved, this study will change T1D care practices by providing high-risk youth with T1D, and their parents, medical and behavioral health support via home telehealth intervention. This has the potential to significantly change access to T1D care, decrease time spent in hyperglycemia, reduce the frequency of hospital admissions, and improve glycemic control. In addition, this study's use of Multiphase Optimization Strategy (MOST), a highly efficient experimental strategy to determine effective intervention components, should be generalizable to all individuals with T1D, leading to cost-effective, home telehealth intervention programs. Innovative aspects include: 1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Read the detailed description
AIM 1: PHASE 1: Use Multiphasic Optimization Strategy (i.e., MOST), a highly efficient experimental strategy, to determine specific components for inclusion in an intervention to 1a) improve primary clinical outcomes of A1C and percentage of time spent in hyperglycemia and 1b) address secondary clinical outcomes by improving adherence and biological markers of complications in high-risk pediatric patients with T1D (A1C=9-12%) as part of 12-month personalized behavioral intervention delivered via in-person T1D clinic visits and home telemedicine.
MOST methodology uses factorial designs and the hypotheses in Aim 1 will be tested through a 2x2 factorial experiment, a highly efficient experimental design despite several common misconceptions about sample size requirements and power. A 2x2 factorial experiment is NOT a 4-arm trial in which each condition is compared in turn to a control condition. In fact, factorial designs do not require a larger number of participants than other designs (e.g., Randomized Controlled Trials (RCT)) and when used to address suitable research questions, they require fewer participants than other designs. Adding factors does not require a dramatic increase in sample size to maintain power.
H1: There will be a main effect of Personalized Adherence Intervention on percentage of A1C, time spent in hyperglycemia, adherence behaviors, and biological markers of complications.
H2: There will be a main effect of Personalized Behavioral Health Intervention on percentage of A1C, time spent in hyperglycemia, adherence behaviors, and biological markers of complications.
AIM 2: PHASE 2: Determine effectiveness of the intervention components on maintenance of A1C, percentage of time spent in hyperglycemia, adherence, and biological markers improvements throughout 6-month follow-up.
H1: Participants who are randomized to T1D medical appointments every 6 weeks will show better improvements in gains in A1C, percentage of time spent in hyperglycemia, adherence, and biological markers compared to those participants who revert to medical appointments occurring every 3 months.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Home Telehealth T1D C2oYoT1-HR, Personalized Behavioral Health, Personalized Adherence Feedback
- Keywords
- pediatrics
- 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.
Home Telehealth T1D C2oYoT1-HRBehavioural
Also called C2oYoT1-HR
- assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Personalized Behavioral HealthBehavioural
Also called C2oYoT1-HR + Behavioral Health
- assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Personalized Adherence FeedbackBehavioural
Also called C2oYoT1-HR + Personalized Adherence Intervention
- assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
| Study group | Role | What they receive |
|---|---|---|
| Home Telehealth T1D (CoYoT1-HR) | Active comparator | Home Telehealth T1D (C2oYoT1-HR), standard of care delivered via Telehealth for high-risk youth Receives: Behavioral: Home Telehealth T1D C2oYoT1-HR |
| Personalized Adherence Feedback | Experimental | C2oYoT1-HR+Personalized Adherence Intervention Receives: Behavioral: Personalized Adherence Feedback |
| Personalized Behavioral Health | Experimental | C2oYoT1-HR+Personalized Behavioral Health Receives: Behavioral: Personalized Behavioral Health |
| C2oYoT1-HR + Adherence + Behavioral | Experimental | C2oYoT1-HR + both Personalized Adherence Feedback + Personalized Behavioral Health (C2oYoT1-HR + Adherence + Behavioral) Receives: Behavioral: Home Telehealth T1D C2oYoT1-HR; Behavioral: Personalized Behavioral Health; Behavioral: Personalized Adherence Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control (A1C): Change from baseline and every 12 weeks up to 72 weeks (18 mo)
A1C will be measured in the central lab located within the Barbara Davis Center at Study Visits 1 (week 1), 5 (week 24) and 9 (week 48), and Follow-Up Visit 2 (week 72) or 4 (week 72) which correspond to in-person T1D visits. In addition, participants will be asked to complete A1C measurements at an outside, independent Certified Laboratory Improvement Amendments (CLIA) lab prior to home telehealth T1D Study Visits 3 (week 12) and 7 (week 36). The rationale for measurement at these study visits is that they occur every 3 months, which is the interval in which A1C is measured as standard of care. Change in A1c will be looked at from baseline every 3 months throughout the study.
Measured: weeks 1, 12, 24, 36, 48, 72
Hyperglycemia - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Time spent in hyperglycemia - change will be looked at from baseline every 12 weeks throughout the study.
Measured: weeks 1, 12, 24, 36, 48, 72
Pediatric Diabetes Quality of Life Scale - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
The PDQ is a 20-question self-administered scale that evaluates and quantifies the quality of life as related to diabetes - change will be looked at from baseline every 3 months throughout the study.
Measured: weeks 1, 12, 24, 36, 48, 72
Secondary outcomes (3)
Adherence - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Objectively Measured Adherence, Self-Reported Adherence, Number of T1D Appointments Attended. - change will be looked at from baseline every 3 months throughout the study.
Measured: weeks 1, 12, 24, 36, 48, 72
Psychosocial Measures - Change from baseline and every 24 weeks up to 72 weeks (18 mo)
Diabetes Family Conflict Scale (DFCS), Diabetes Family Responsibility Questionnaire (DFRQ), Hypoglycemia Fear Scale (HFS), Patient Health Questionnaire - 9 (PHQ-9), Problem Area in Diabetes Version (PAID), Puberty - change will be looked at from baseline every 3 months throughout the study.
Measured: weeks 1, 24, 48, 72
Biological Markers of T1D Complications - Change from baseline and every 24 weeks up to 72 weeks (18 mo)
Urinary microalbumin, endothelial function - change will be looked at from baseline every 3 months throughout the study.
Measured: weeks 1, 24, 48, 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Nov 2017
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Factorial
- Model description
- MOST methodology uses factorial designs and the hypotheses in Aim 1 will be tested through a 2x2 factorial experiment, a highly efficient experimental design despite several common misconceptions about sample size requirements and power. A 2x2 factorial experiment is NOT a 4-arm trial in which each condition is compared in turn to a control condition. In fact, factorial designs do not require a larger number of participants than other designs (e.g., RCT) and when used to address suitable research questions, they require fewer participants than other designs. Adding factors does not require a dramatic increase in sample size to maintain power. The number of arms is listed below as 4 as # of arms is required by the clinicaltrails.gov site; please refer above for a more accurate description of the study design.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly A Driscoll, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324438
- Sponsor's protocol ID
- 17-0004
- Other IDs
- DP3DK113363
- Status last verified
- Jul 2022
- First submitted
- 21 Aug 2017
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing will occur at this point.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Telemedicine to Optimize Health Outcomes in High-Risk Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03324438
- Acronym / sponsor ID
- 17-0004
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 27 Oct 2017 (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 addresses the critical need for improving Type 1 Diabetes (T1D) health outcomes in high-risk youth (A1C=9-12%; ages 10-17 yrs) (AIC: glycated hemoglobin) where suboptimal glycemic control has severe acute and long-term complications with potentially life threatening consequences. Lack of regular contact with T1D care providers, continued T1D nonadherence, and suboptimal behavioral and mental health functioning compromises the physical health of youth with T1D and the ability of T1D teams to provide effective treatment. If the aims of this study are achieved, this study will change T1D care practices by providing high-risk youth with T1D, and their parents, medical and behavioral health support via home telehealth intervention. This has the potential to significantly change access to T1D care, decrease time spent in hyperglycemia, reduce the frequency of hospital admissions, and improve glycemic control. In addition, this study's use of Multiphase Optimization Strategy (MOST), a highly efficient experimental strategy to determine effective intervention components, should be generalizable to all individuals with T1D, leading to cost-effective, home telehealth intervention programs. Innovative aspects include: 1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
Detailed description
AIM 1: PHASE 1: Use Multiphasic Optimization Strategy (i.e., MOST), a highly efficient experimental strategy, to determine specific components for inclusion in an intervention to 1a) improve primary clinical outcomes of A1C and percentage of time spent in hyperglycemia and 1b) address secondary clinical outcomes by improving adherence and biological markers of complications in high-risk pediatric patients with T1D (A1C=9-12%) as part of 12-month personalized behavioral intervention delivered via in-person T1D clinic visits and home telemedicine.
MOST methodology uses factorial designs and the hypotheses in Aim 1 will be tested through a 2x2 factorial experiment, a highly efficient experimental design despite several common misconceptions about sample size requirements and power. A 2x2 factorial experiment is NOT a 4-arm trial in which each condition is compared in turn to a control condition. In fact, factorial designs do not require a larger number of participants than other designs (e.g., Randomized Controlled Trials (RCT)) and when used to address suitable research questions, they require fewer participants than other designs. Adding factors does not require a dramatic increase in sample size to maintain power.
H1: There will be a main effect of Personalized Adherence Intervention on percentage of A1C, time spent in hyperglycemia, adherence behaviors, and biological markers of complications.
H2: There will be a main effect of Personalized Behavioral Health Intervention on percentage of A1C, time spent in hyperglycemia, adherence behaviors, and biological markers of complications.
AIM 2: PHASE 2: Determine effectiveness of the intervention components on maintenance of A1C, percentage of time spent in hyperglycemia, adherence, and biological markers improvements throughout 6-month follow-up.
H1: Participants who are randomized to T1D medical appointments every 6 weeks will show better improvements in gains in A1C, percentage of time spent in hyperglycemia, adherence, and biological markers compared to those participants who revert to medical appointments occurring every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- MOST methodology uses factorial designs and the hypotheses in Aim 1 will be tested through a 2x2 factorial experiment, a highly efficient experimental design despite several common misconceptions about sample size requirements and power. A 2x2 factorial experiment is NOT a 4-arm trial in which each condition is compared in turn to a control condition. In fact, factorial designs do not require a larger number of participants than other designs (e.g., RCT) and when used to address suitable research questions, they require fewer participants than other designs. Adding factors does not require a dramatic increase in sample size to maintain power. The number of arms is listed below as 4 as # of arms is required by the clinicaltrails.gov site; please refer above for a more accurate description of the study design.
| Arm | Type | Receives |
|---|---|---|
| Home Telehealth T1D (CoYoT1-HR) | Active comparator | Behavioral: Home Telehealth T1D C2oYoT1-HRHome Telehealth T1D (C2oYoT1-HR), standard of care delivered via Telehealth for high-risk youth |
| Personalized Adherence Feedback | Experimental | Behavioral: Personalized Adherence FeedbackC2oYoT1-HR+Personalized Adherence Intervention |
| Personalized Behavioral Health | Experimental | Behavioral: Personalized Behavioral HealthC2oYoT1-HR+Personalized Behavioral Health |
| C2oYoT1-HR + Adherence + Behavioral | Experimental | Behavioral: Home Telehealth T1D C2oYoT1-HR, Behavioral: Personalized Behavioral Health, Behavioral: Personalized Adherence FeedbackC2oYoT1-HR + both Personalized Adherence Feedback + Personalized Behavioral Health (C2oYoT1-HR + Adherence + Behavioral) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- youth age 10-17 years
- A1C=9-12%
- parent(s) of child with confirmed diagnosis of T1D
- T1D duration >1 year
- parent and child agree to participate in home telehealth sessions
Key exclusion criteria (6 listed)
- developmental disability or reading disorder that prevents understanding of the intervention materials
- non-English speaking adolescents
- those with severe psychological disorders
- prescribed and taking medications that increase blood glucoses
- not seen in T1D clinic within the past year; pregnant if female; situational concerns (e.g., active custody battle)
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 |
|---|---|---|
| Home Telehealth T1D C2oYoT1-HRAlso: C2oYoT1-HR1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care. | Behavioural | C2oYoT1-HR + Adherence + Behavioral, Home Telehealth T1D (CoYoT1-HR) |
| Personalized Behavioral HealthAlso: C2oYoT1-HR + Behavioral Health1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care. | Behavioural | C2oYoT1-HR + Adherence + Behavioral, Personalized Behavioral Health |
| Personalized Adherence FeedbackAlso: C2oYoT1-HR + Personalized Adherence Intervention1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care. | Behavioural | C2oYoT1-HR + Adherence + Behavioral, Personalized Adherence Feedback |
Primary outcome
Glycemic control (A1C): Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Time frame: weeks 1, 12, 24, 36, 48, 72
A1C will be measured in the central lab located within the Barbara Davis Center at Study Visits 1 (week 1), 5 (week 24) and 9 (week 48), and Follow-Up Visit 2 (week 72) or 4 (week 72) which correspond to in-person T1D visits. In addition, participants will be asked to complete A1C measurements at an outside, independent Certified Laboratory Improvement Amendments (CLIA) lab prior to home telehealth T1D Study Visits 3 (week 12) and 7 (week 36). The rationale for measurement at these study visits is that they occur every 3 months, which is the interval in which A1C is measured as standard of care. Change in A1c will be looked at from baseline every 3 months throughout the study.
Hyperglycemia - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Time frame: weeks 1, 12, 24, 36, 48, 72
Time spent in hyperglycemia - change will be looked at from baseline every 12 weeks throughout the study.
Pediatric Diabetes Quality of Life Scale - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Time frame: weeks 1, 12, 24, 36, 48, 72
The PDQ is a 20-question self-administered scale that evaluates and quantifies the quality of life as related to diabetes - change will be looked at from baseline every 3 months throughout the study.
3 secondary outcomes
Adherence - Change from baseline and every 12 weeks up to 72 weeks (18 mo)
Time frame: weeks 1, 12, 24, 36, 48, 72
Psychosocial Measures - Change from baseline and every 24 weeks up to 72 weeks (18 mo)
Time frame: weeks 1, 24, 48, 72
Biological Markers of T1D Complications - Change from baseline and every 24 weeks up to 72 weeks (18 mo)
Time frame: weeks 1, 24, 48, 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No. no sharing will occur at this point.
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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.
Kimberly A Driscoll, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Telehealth T1D C2oYoT1-HR, Personalized Behavioral Health and Personalized Adherence Feedback in people with Type 1 Diabetes Mellitus, run by University of Colorado, Denver 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 6 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 21 Jul 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (A1C): Change from baseline and every 12 weeks up to 72 weeks (18 mo) (time frame: weeks 1, 12, 24, 36, 48, 72). The study lists 3 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 21 Jul 2022.