Diabetes Mellitus, Type 2NCT05541120
Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals With Type 2 Diabetes
A study testing Remote Patient Monitoring in people with Diabetes Mellitus, Type 2, run by Tracy Jalbuena MD at 1 site in United States.
Trial summary
This is a randomized controlled trial of the use of Remote Patient Monitoring (RPM) compared to usual care among rural patients with poorly controlled type 2 diabetes. Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program and Primary Care Provider evaluation and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Remote Patient Monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 31 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be enrolled in Living Well with Diabetes education program
- Have an HbA1c% ≥ 8 in the prior 6 months
- Be capable of providing consent
- Be adults (age 18 or over)
Who cannot join
- Primarily managed by endocrinology for their diabetes (> 1 visit with endocrinology in the previous 12 months)
- Incarcerated
- PCP not at one of the 30 primary care practices listed (see attachment List of PCP Practices)
- Diagnosed with type 1 diabetes
- Candidate for continuous glucose monitoring, as defined by Centers for Medicare and Medicaid Services as using at least three insulin injections per day, any combination of types of insulins
- Pregnant
Show all 12Show fewer
- Have previously participated in the Living Well with Diabetes/Virtual Diabetes Self-Management Program
- Have previously used a remote patient monitoring device for diabetes management
- Have a diagnosis of dementia or other clinical diagnosis that would impair participation capacity
- Currently participating in any other clinical trial regarding diabetes care or management
- Currently enrolled in hospice
- Currently residing in a long term care or rehabilitation facility
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled trial of the use of Remote Patient Monitoring (RPM) compared to usual care among rural patients with poorly controlled type 2 diabetes. Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program and Primary Care Provider evaluation and management at the providers' discretion, including medication adjustment or interventions, and other types of interventions depending on clinical judgement.
Read the detailed description
Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals with Type 2 Diabetes
Summary
ABSTRACT
In 2021, the MaineHealth Telehealth team was awarded a five-year, $1.7 million "Evidence-Based Telehealth Network Program" grant (EB TNPG) from Health Resources and Services Administration (HRSA). This grant is aimed at improving patient access to educational and management services for patients with type 2 diabetes in the rural Maine primary care setting by implementing RPM. The RPM devices will be used to transmit a participant's home point-of-care blood glucose values directly into MaineHealth's electronic medical record in real time. While there is strong evidence for diabetes self-management programs such as Living Well with Diabetes, the importance of patient engagement in clinical outcomes, the validity of the Patient Activation Measure (PAM-13®) survey to measure patient activation, and the overall efficacy of remote patient monitoring, there have been no randomized controlled trials looking at patient activation in remote patient monitoring in this important patient group. The investigators aim to address this in this study by conducting a randomized controlled trial of the use of RPM among rural patients with poorly controlled type 2 diabetes. The control group will have usual primary care provider care, including patient self-management tools, while the intervention group will have usual care + RPM.
The investigators hypothesize that participation in RPM will be associated with decreases in HbA1c, increases in patient activation as measured by PAM-13® survey, and that increases in patient activation will be associated with decreases in HbA1c.
STUDY PROCESS
The study will be conducted over 5 years, and participants will be enrolled on a continuous rolling basis, with 70 total RPM kits available at any one time from a 3rd party vendor, Health Recovery Solutions (HRS). The maximum total number of participants the study can accommodate is 700, with 350 participants in each arm. The study team hopes for total enrollment as close to 700 as possible, but understands that total enrollment may be significantly less than 700. Point-of-care blood glucose values from the RPM study arm will flow into MaineHealth's electronic medical record (Epic) in real time. Every other week, the values will be reviewed by a clinical pharmacist with expertise in diabetes management. If an intervention or adjustment in the patient's regimen is indicated, the pharmacist will reach out to the Primary Care Provider (PCP) team to make this recommendation. The RPM intervention for each participant will be 6 months, at which point HRS will collect the RPM electronic tablet, and the PAM-13® survey will be administered. At 9 months after enrollment, the third HbA1c value will be collected from the electronic medical record, and the third administration of PAM-13® will take place.
The PAM-13® survey will be administered through one of two methods 1) REDCap electronic form, the link for which will be sent to the participant by email, or 2) by telephone, administered by the Study Coordinator.
Recruitment of participants will continue through the early part of 2026. Data will be analyzed during spring and summer of 2026, and the grant's end date is August 31, 2026.
This study has been approved by MaineHealth's IRB as of Aug 5, 2022.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Remote Patient Monitoring
- Keywords
- remote patient monitoring, glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient MonitoringDevice
Remote patient monitoring as the intervention is defined as a tablet and Bluetooth-enabled glucometer technology that collects point-of-care (POC) blood glucose data from a patient outside of a traditional clinical setting, and securely transmits this data to Epic for review and potential intervention.
| Study group | Role | What they receive |
|---|---|---|
| Living Well with Diabetes | No intervention | Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program, PCP evaluation and management, including medication adjustment or interventions, and other types of interventions depending on clinical judgement. This may include eConsults between the provider and a pharmacist, in-person visits between the provider and the patient, synchronous telemedicine visits between the provider and the patient, and synchronous telemedicine visits between the pharmacist and the patient. |
| Living Well with Diabetes + Remote Patient Monitoring | Experimental | Remote patient monitoring as the intervention is defined as a tablet and Bluetooth-enabled glucometer technology that collects point-of-care (POC) blood glucose data from a patient outside of a traditional clinical setting, and securely transmits this data to Epic for review and potential intervention. Receives: Device: Remote Patient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean HbA1c%
Average glycated hemoglobin
Measured: 6 months after enrollment
Mean HbA1c%
Average glycated hemoglobin
Measured: 9 months after enrollment
Mean change in HbA1c%
Average change in percentage of HbA1c from baseline to 6 months after enrollment
Measured: 6 months after enrollment
Mean change in HbA1c%
Average change in percentage of HbA1c from baseline to 9 months after enrollment
Measured: 9 months after enrollment
Percentage of participants in each group who have HbA1c < 7%
Percentage of participants in each group with HbA1c < 7%
Measured: 6 months after enrollment
Percentage of participants in each group who have HbA1c < 7%
Percentage of participants in each group with HbA1c < 7%
Measured: 9 months after enrollment
Secondary outcomes (4)
PAM-13 at 6 months after enrollment
PAM-13 Patient Activation Measure Survey
Unabbreviated scale title: Patient Activation Measure 13-Item Survey Minimum value: 0 Maximum value: 100 Higher values are associated with better health outcomes
Measured: 6 months after enrollment
PAM-13 at 9 months after enrollment
PAM-13 Patient Activation Measure Survey
PAM-13 Patient Activation Measure Survey
Unabbreviated scale title: Patient Activation Measure 13-Item Survey Minimum value: 0 Maximum value: 100 Higher values are associated with better health outcomes
Measured: 9 months after enrollment
Mean change in PAM-13 at 6 months
Average change in PAM-13 Patient Activation Measure Survey score from baseline to 6 months after enrollment
Unabbreviated scale title: Patient Activation Measure 13-Item Survey Minimum value: 0 Maximum value: 100 Higher values are associated with better health outcomes
Measured: 6 months after enrollment
Mean change in PAM-13 at 9 months
Average change in PAM-13 Patient Activation Measure Survey score from baseline to 9 months after enrollment
Unabbreviated scale title: Patient Activation Measure 13-Item Survey Minimum value: 0 Maximum value: 100 Higher values are associated with better health outcomes
Measured: 9 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start18 Oct 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Why it stopped: Lack of participants eligible for study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled trial of the use of RPM compared to usual care among MaineHealth's rural patients with poorly controlled diabetes, where the participant's diabetes is managed primarily by primary care (as opposed to endocrinology). Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program, PCP evaluation and management at the providers' discretion, including medication adjustment or interventions, and other types of interventions depending on clinical judgement. This may include eConsults between the provider and a pharmacist, in-person visits between the provider and the patient, synchronous telemedicine visits between the provider and the patient, and synchronous telemedicine visits between the pharmacist and the patient.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tracy Jalbuena MD
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth, Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor-investigator, Tracy Jalbuena MD, MaineHealth
- Investigators
- Tracy Jalbuena, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541120
- Sponsor's protocol ID
- 00000
- Status last verified
- Feb 2023
- First submitted
- 30 Aug 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almutairi N, Hosseinzadeh H, Gopaldasani V. The effectiveness of patient activation intervention on type 2 diabetes mellitus glycemic control and self-management behaviors: A systematic review of RCTs. Prim Care Diabetes. 2020 Feb;14(1):12-20. doi: 10.1016/j.pcd.2019.08.009. Epub 2019 Sep 20.
PubMed 31543458American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018 May;41(5):917-928. doi: 10.2337/dci18-0007. Epub 2018 Mar 22.
PubMed 29567642Andersen JA, Scoggins D, Michaud T, Wan N, Wen M, Su D. Racial Disparities in Diabetes Management Outcomes: Evidence from a Remote Patient Monitoring Program for Type 2 Diabetic Patients. Telemed J E Health. 2021 Jan;27(1):55-61. doi: 10.1089/tmj.2019.0280. Epub 2020 Apr 17.
PubMed 32302521Bahrom NH, Ramli AS, Isa MR, Baharudin N, Badlishah-Sham SF, Mohamed-Yassin MS, Abdul-Hamid H. Validity and reliability of the Patient Activation Measure(R) (PAM(R))-13 Malay version among patients with Metabolic Syndrome in primary care. Malays Fam Physician. 2020 Nov 10;15(3):22-34. eCollection 2020.
PubMed 33329860Bomba F, Markwart H, Muhlan H, Menrath I, Ernst G, Thyen U, Schmidt S. Adaptation and validation of the German Patient Activation Measure for adolescents with chronic conditions in transitional care: PAM(R) 13 for Adolescents. Res Nurs Health. 2018 Feb;41(1):78-87. doi: 10.1002/nur.21831. Epub 2017 Dec 20.
PubMed 29266283Boren SA, Fitzner KA, Panhalkar PS, Specker JE. Costs and benefits associated with diabetes education: a review of the literature. Diabetes Educ. 2009 Jan-Feb;35(1):72-96. doi: 10.1177/0145721708326774.
PubMed 19244564Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010 Oct 22;8:29. doi: 10.1186/1478-7954-8-29.
PubMed 20969750Brenk-Franz K, Hibbard JH, Herrmann WJ, Freund T, Szecsenyi J, Djalali S, Steurer-Stey C, Sonnichsen A, Tiesler F, Storch M, Schneider N, Gensichen J. Validation of the German version of the patient activation measure 13 (PAM13-D) in an international multicentre study of primary care patients. PLoS One. 2013 Sep 30;8(9):e74786. doi: 10.1371/journal.pone.0074786. eCollection 2013.
PubMed 24098669Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: A systematic review of the effect on glycemic control. Patient Educ Couns. 2016 Jun;99(6):926-43. doi: 10.1016/j.pec.2015.11.003. Epub 2015 Nov 22.
PubMed 26658704Cunha CM, da Cunha DCPT, Manzato RO, Nepomuceno E, da Silva D, Dantas RAS. Validation of the Brazilian Version of the Patient Activation Measure 13. J Nurs Meas. 2019 Apr 1;27(1):97-113. doi: 10.1891/1061-3749.27.1.97.
PubMed 31068494Dieleman JL, Baral R, Birger M, Bui AL, Bulchis A, Chapin A, Hamavid H, Horst C, Johnson EK, Joseph J, Lavado R, Lomsadze L, Reynolds A, Squires E, Campbell M, DeCenso B, Dicker D, Flaxman AD, Gabert R, Highfill T, Naghavi M, Nightingale N, Templin T, Tobias MI, Vos T, Murray CJ. US Spending on Personal Health Care and Public Health, 1996-2013. JAMA. 2016 Dec 27;316(24):2627-2646. doi: 10.1001/jama.2016.16885.
PubMed 28027366Egede LE, Williams JS, Voronca DC, Knapp RG, Fernandes JK. Randomized Controlled Trial of Technology-Assisted Case Management in Low Income Adults with Type 2 Diabetes. Diabetes Technol Ther. 2017 Aug;19(8):476-482. doi: 10.1089/dia.2017.0006. Epub 2017 Jun 5.
PubMed 28581821Fowles JB, Terry P, Xi M, Hibbard J, Bloom CT, Harvey L. Measuring self-management of patients' and employees' health: further validation of the Patient Activation Measure (PAM) based on its relation to employee characteristics. Patient Educ Couns. 2009 Oct;77(1):116-22. doi: 10.1016/j.pec.2009.02.018. Epub 2009 Apr 7.
PubMed 19356881Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care. 2005 May;43(5):436-44. doi: 10.1097/01.mlr.0000160375.47920.8c.
PubMed 15838407Greene J, Hibbard JH. Why does patient activation matter? An examination of the relationships between patient activation and health-related outcomes. J Gen Intern Med. 2012 May;27(5):520-6. doi: 10.1007/s11606-011-1931-2.
PubMed 22127797
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05541120
- Acronym / sponsor ID
- 00000
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- remote patient monitoring, glycemic control
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of participants eligible for study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tracy Jalbuena MDUniversity, hospital or other
- Collaborators
- MaineHealth, Health Resources and Services Administration (HRSA)
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 15 Sep 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 is a randomized controlled trial of the use of Remote Patient Monitoring (RPM) compared to usual care among rural patients with poorly controlled type 2 diabetes. Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program and Primary Care Provider evaluation and management at the providers' discretion, including medication adjustment or interventions, and other types of interventions depending on clinical judgement.
Detailed description
Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals with Type 2 Diabetes
Summary
ABSTRACT
In 2021, the MaineHealth Telehealth team was awarded a five-year, $1.7 million "Evidence-Based Telehealth Network Program" grant (EB TNPG) from Health Resources and Services Administration (HRSA). This grant is aimed at improving patient access to educational and management services for patients with type 2 diabetes in the rural Maine primary care setting by implementing RPM. The RPM devices will be used to transmit a participant's home point-of-care blood glucose values directly into MaineHealth's electronic medical record in real time. While there is strong evidence for diabetes self-management programs such as Living Well with Diabetes, the importance of patient engagement in clinical outcomes, the validity of the Patient Activation Measure (PAM-13®) survey to measure patient activation, and the overall efficacy of remote patient monitoring, there have been no randomized controlled trials looking at patient activation in remote patient monitoring in this important patient group. The investigators aim to address this in this study by conducting a randomized controlled trial of the use of RPM among rural patients with poorly controlled type 2 diabetes. The control group will have usual primary care provider care, including patient self-management tools, while the intervention group will have usual care + RPM.
The investigators hypothesize that participation in RPM will be associated with decreases in HbA1c, increases in patient activation as measured by PAM-13® survey, and that increases in patient activation will be associated with decreases in HbA1c.
STUDY PROCESS
The study will be conducted over 5 years, and participants will be enrolled on a continuous rolling basis, with 70 total RPM kits available at any one time from a 3rd party vendor, Health Recovery Solutions (HRS). The maximum total number of participants the study can accommodate is 700, with 350 participants in each arm. The study team hopes for total enrollment as close to 700 as possible, but understands that total enrollment may be significantly less than 700. Point-of-care blood glucose values from the RPM study arm will flow into MaineHealth's electronic medical record (Epic) in real time. Every other week, the values will be reviewed by a clinical pharmacist with expertise in diabetes management. If an intervention or adjustment in the patient's regimen is indicated, the pharmacist will reach out to the Primary Care Provider (PCP) team to make this recommendation. The RPM intervention for each participant will be 6 months, at which point HRS will collect the RPM electronic tablet, and the PAM-13® survey will be administered. At 9 months after enrollment, the third HbA1c value will be collected from the electronic medical record, and the third administration of PAM-13® will take place.
The PAM-13® survey will be administered through one of two methods 1) REDCap electronic form, the link for which will be sent to the participant by email, or 2) by telephone, administered by the Study Coordinator.
Recruitment of participants will continue through the early part of 2026. Data will be analyzed during spring and summer of 2026, and the grant's end date is August 31, 2026.
This study has been approved by MaineHealth's IRB as of Aug 5, 2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial of the use of RPM compared to usual care among MaineHealth's rural patients with poorly controlled diabetes, where the participant's diabetes is managed primarily by primary care (as opposed to endocrinology). Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program, PCP evaluation and management at the providers' discretion, including medication adjustment or interventions, and other types of interventions depending on clinical judgement. This may include eConsults between the provider and a pharmacist, in-person visits between the provider and the patient, synchronous telemedicine visits between the provider and the patient, and synchronous telemedicine visits between the pharmacist and the patient.
| Arm | Type | Receives |
|---|---|---|
| Living Well with Diabetes | No intervention | –Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program, PCP evaluation and management, including medication adjustment or interventions, and other types of interventions depending on clinical judgement. This may include eConsults between the provider and a pharmacist, in-person visits between the provider and the patient, synchronous telemedicine visits between the provider and the patient, and synchronous telemedicine visits between the pharmacist and the patient. |
| Living Well with Diabetes + Remote Patient Monitoring | Experimental | Device: Remote Patient MonitoringRemote patient monitoring as the intervention is defined as a tablet and Bluetooth-enabled glucometer technology that collects point-of-care (POC) blood glucose data from a patient outside of a traditional clinical setting, and securely transmits this data to Epic for review and potential intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be enrolled in Living Well with Diabetes education program
- Have an HbA1c% ≥ 8 in the prior 6 months
- Be capable of providing consent
- Be adults (age 18 or over)
Key exclusion criteria (12 listed)
- Primarily managed by endocrinology for their diabetes (> 1 visit with endocrinology in the previous 12 months)
- Incarcerated
- PCP not at one of the 30 primary care practices listed (see attachment List of PCP Practices)
- Diagnosed with type 1 diabetes
- Candidate for continuous glucose monitoring, as defined by Centers for Medicare and Medicaid Services as using at least three insulin injections per day, any combination of types of insulins
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 |
|---|---|---|
| Remote Patient MonitoringRemote patient monitoring as the intervention is defined as a tablet and Bluetooth-enabled glucometer technology that collects point-of-care (POC) blood glucose data from a patient outside of a traditional clinical setting, and securely transmits this data to Epic for review and potential intervention. | Device | Living Well with Diabetes + Remote Patient Monitoring |
Primary outcome
Mean HbA1c%
Time frame: 6 months after enrollment
Average glycated hemoglobin
Mean HbA1c%
Time frame: 9 months after enrollment
Average glycated hemoglobin
Mean change in HbA1c%
Time frame: 6 months after enrollment
Average change in percentage of HbA1c from baseline to 6 months after enrollment
Mean change in HbA1c%
Time frame: 9 months after enrollment
Average change in percentage of HbA1c from baseline to 9 months after enrollment
Percentage of participants in each group who have HbA1c < 7%
Time frame: 6 months after enrollment
Percentage of participants in each group with HbA1c < 7%
Percentage of participants in each group who have HbA1c < 7%
Time frame: 9 months after enrollment
Percentage of participants in each group with HbA1c < 7%
4 secondary outcomes
PAM-13 at 6 months after enrollment
Time frame: 6 months after enrollment
PAM-13 at 9 months after enrollment
Time frame: 9 months after enrollment
Mean change in PAM-13 at 6 months
Time frame: 6 months after enrollment
Mean change in PAM-13 at 9 months
Time frame: 9 months after enrollment
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 16 Feb 2023.
- Background: PubMed 31543458Almutairi N, Hosseinzadeh H, Gopaldasani V. The effectiveness of patient activation intervention on type 2 diabetes mellitus glycemic control and self-management behaviors: A systematic review of RCTs. Prim Care Diabetes. 2020 Feb;14(1):12-20. doi: 10.1016/j.pcd.2019.08.009. Epub 2019 Sep 20.
- Background: PubMed 29567642American Diabetes Association. Economic Costs of Diabetes in the U.S. in 2017. Diabetes Care. 2018 May;41(5):917-928. doi: 10.2337/dci18-0007. Epub 2018 Mar 22.
- Background: PubMed 32302521Andersen JA, Scoggins D, Michaud T, Wan N, Wen M, Su D. Racial Disparities in Diabetes Management Outcomes: Evidence from a Remote Patient Monitoring Program for Type 2 Diabetic Patients. Telemed J E Health. 2021 Jan;27(1):55-61. doi: 10.1089/tmj.2019.0280. Epub 2020 Apr 17.
- Background: PubMed 33329860Bahrom NH, Ramli AS, Isa MR, Baharudin N, Badlishah-Sham SF, Mohamed-Yassin MS, Abdul-Hamid H. Validity and reliability of the Patient Activation Measure(R) (PAM(R))-13 Malay version among patients with Metabolic Syndrome in primary care. Malays Fam Physician. 2020 Nov 10;15(3):22-34. eCollection 2020.
- Background: PubMed 29266283Bomba F, Markwart H, Muhlan H, Menrath I, Ernst G, Thyen U, Schmidt S. Adaptation and validation of the German Patient Activation Measure for adolescents with chronic conditions in transitional care: PAM(R) 13 for Adolescents. Res Nurs Health. 2018 Feb;41(1):78-87. doi: 10.1002/nur.21831. Epub 2017 Dec 20.
- Background: PubMed 19244564Boren SA, Fitzner KA, Panhalkar PS, Specker JE. Costs and benefits associated with diabetes education: a review of the literature. Diabetes Educ. 2009 Jan-Feb;35(1):72-96. doi: 10.1177/0145721708326774.
- Background: PubMed 20969750Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010 Oct 22;8:29. doi: 10.1186/1478-7954-8-29.
- Background: PubMed 24098669Brenk-Franz K, Hibbard JH, Herrmann WJ, Freund T, Szecsenyi J, Djalali S, Steurer-Stey C, Sonnichsen A, Tiesler F, Storch M, Schneider N, Gensichen J. Validation of the German version of the patient activation measure 13 (PAM13-D) in an international multicentre study of primary care patients. PLoS One. 2013 Sep 30;8(9):e74786. doi: 10.1371/journal.pone.0074786. eCollection 2013.
- Background: PubMed 26658704Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: A systematic review of the effect on glycemic control. Patient Educ Couns. 2016 Jun;99(6):926-43. doi: 10.1016/j.pec.2015.11.003. Epub 2015 Nov 22.
- Background: PubMed 31068494Cunha CM, da Cunha DCPT, Manzato RO, Nepomuceno E, da Silva D, Dantas RAS. Validation of the Brazilian Version of the Patient Activation Measure 13. J Nurs Meas. 2019 Apr 1;27(1):97-113. doi: 10.1891/1061-3749.27.1.97.
- Background: PubMed 28027366Dieleman JL, Baral R, Birger M, Bui AL, Bulchis A, Chapin A, Hamavid H, Horst C, Johnson EK, Joseph J, Lavado R, Lomsadze L, Reynolds A, Squires E, Campbell M, DeCenso B, Dicker D, Flaxman AD, Gabert R, Highfill T, Naghavi M, Nightingale N, Templin T, Tobias MI, Vos T, Murray CJ. US Spending on Personal Health Care and Public Health, 1996-2013. JAMA. 2016 Dec 27;316(24):2627-2646. doi: 10.1001/jama.2016.16885.
- Background: PubMed 28581821Egede LE, Williams JS, Voronca DC, Knapp RG, Fernandes JK. Randomized Controlled Trial of Technology-Assisted Case Management in Low Income Adults with Type 2 Diabetes. Diabetes Technol Ther. 2017 Aug;19(8):476-482. doi: 10.1089/dia.2017.0006. Epub 2017 Jun 5.
- Centers For Disease Control and Prevention. National Diabetes Statistics Report, 2020: Estimates of Diabetes and Its Burden in the United States. U.S. Department of Health and Human Services; 2020.Link provided by the sponsor.
- Centers For Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of Population Health. BRFSS Prevalence \& Trend DataLink provided by the sponsor.
- Centers for Medicare and Medicaid Services. DM-2 (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (\>9%).; 2019. Accessed January 20, 2022.Link provided by the sponsor.
- International Diabetes Federation. IDF Diabetes Atlas. IDF Diabetes Atlas. Published 2021Link provided by the sponsor.
- Lisa A. States with the biggest rural populations. Stacker. Published April 8, 2019.Link provided by the sponsor.
- National Clinical Care Commission. Report to Congress on Leveraging Federal Programs to Prevent and Control Diabetes and Its Complications. Department of Health and Human Services; 2021. Accessed January 31, 2022.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Chronic Kidney Disease, Hypertension (HTN)
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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Tracy Jalbuena, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Patient Monitoring in people with Diabetes Mellitus, Type 2, run by Tracy Jalbuena MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 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 16 Feb 2023. 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?
Mean HbA1c% (time frame: 6 months after enrollment). The study lists 6 primary outcomes in all. 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 NCT05541120, which also lists 53 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 16 Feb 2023.