My Diabetes Care for Diabetes

No longer recruiting at 1 trial location

Overseen By Audriana Nigg, BA (Study Coordinator)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must be taking: Diabetes medications

Disqualifiers: Dialysis, Pregnancy, Long-term care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a special patient portal, My Diabetes Care (MDC), can improve Type 2 diabetes management. Participants will either use MDC, which offers additional tools and resources, or continue with usual care through their existing patient web portal. The trial seeks individuals with Type 2 diabetes who take at least one diabetes medication and have internet access. Participants should be patients at Vanderbilt University Medical Center or Brigham and Women's Hospital. As an unphased trial, this study provides a unique opportunity to explore innovative diabetes management methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications, but it does require that you are currently taking at least one medication for diabetes.

What prior data suggests that this patient portal intervention is safe for diabetes care?

Research has shown that My Diabetes Care (MDC) is a new tool to help people with diabetes manage their health. It operates through an online platform known as a patient web portal. This tool enhances patients' understanding of their health information and supports their diabetes care.

The safety of using MDC primarily concerns the ease of portal use without issues. A study on its usability found it easy to navigate, with no major problems for users. Reports of harmful effects from using this type of online support system are absent.

Since MDC is a digital tool and not a medication, the focus is more on its effectiveness and user experience rather than physical side effects. Overall, MDC appears to be a well-tolerated and helpful addition for managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the My Diabetes Care platform because it offers a more integrated approach to managing diabetes. Unlike traditional care that relies on standard patient web portals, My Diabetes Care is embedded into Epic's MyChart, providing patients with a personalized and interactive experience. This integration could lead to better patient engagement and more effective self-management of diabetes, potentially improving outcomes compared to usual care options.

What evidence suggests that My Diabetes Care is effective for diabetes?

Research has shown that programs designed to help manage diabetes can be very effective, especially for people with higher-than-recommended blood sugar levels. One study found that these programs improve health by helping people control their blood sugar better. Another study showed that digital tools, like a diabetes logbook, significantly reduce the stress of managing diabetes. Education on self-managing diabetes has led to healthier lifestyle choices and better self-care for those with type 2 diabetes. Improvements in important health measures, like HbA1c (which shows average blood sugar over a few months), have been observed with a mix of in-person and digital diabetes care, particularly for those starting with higher blood sugar levels.

In this trial, participants will either have access to the My Diabetes Care program embedded in a patient web portal or receive usual care without this program. The study aims to evaluate the effectiveness of the My Diabetes Care program in improving diabetes management. ^{6 7 8 9 10}

Who Is on the Research Team?

William Martinez, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with Type 2 Diabetes who are on medication, can use a smartphone or computer with internet, and have an active patient web portal account at VUMC or BWH. They must be able to understand English or Spanish. Those on dialysis, pregnant, or in long-term care cannot join.

Inclusion Criteria

Have reliable access to a smartphone, tablet, or computer with internet access

I have Type 2 Diabetes.

You are a patient at Vanderbilt University Medical Center or Brigham and Women's Hospital.

Exclusion Criteria

I am currently on dialysis.

Pregnant or planning to become pregnant within the next year

Living in a long-term care facility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Baseline Assessment

Baseline data collection including electronic consent and randomization

1 week

1 visit (virtual)

Intervention

Participants receive access to My Diabetes Care or usual care via patient web portal

12 months

Ongoing access with electronic data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 follow-up assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• My Diabetes Care

Trial Overview The study tests 'My Diabetes Care', a patient portal intervention designed to improve diabetes management through technology. Participants will be randomly assigned to two groups: one using the MDC system and the other continuing usual care.

How Is the Trial Designed?

Group I: My Diabetes Care Experimental Treatment 1 Intervention

Patients have access to an existing patient web portal (i.e., Epic's MyChart) embedded with My Diabetes Care.

Group II: Usual Care Active Control 1 Intervention

Patients will have access to an existing patient web portal (i.e., Epic's MyChart) NOT embedded with My Diabetes Care (i.e., usual care)

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A systematic review of 27 studies identified 53 patient-reported outcomes that are important for managing diabetes, focusing on aspects like psychological well-being and self-management behaviors.

Diabetes distress and self-management behaviors were particularly emphasized as critical outcomes, suggesting that addressing these areas could significantly enhance patient care and outcomes in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which diabetes specific patient reported outcomes should be measured in routine care? A systematic review to inform a core outcome set for adults with Type 1 and 2 diabetes mellitus: The European Health Outcomes Observatory (H2O) programme. Hamilton, K., Forde, R., Due-Christensen, M., et al.[2023]

Educational interventions for healthcare professionals, including a 6-hour standardized course, significantly improved their attitudes and motivation towards monitoring diabetes, which is crucial for patient safety.

The study suggests that these interventions can enhance the control of diabetes in patients, as measured by HbA1c levels, although the specific outcomes on patient control were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. Cabré, JJ., Ripoll, M., Hernández, JM., et al.[2021]

A comprehensive analysis of the National Reporting and Learning System database revealed that patient safety incidents involving insulin are common and lead to significant distress for individuals with diabetes and their families, highlighting a critical area for improvement in diabetes care.

The article discusses ongoing efforts by the National Patient Safety Agency and partner organizations aimed at reducing insulin-related errors, indicating a proactive approach to enhancing patient safety in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin, hospitals and harm: a review of patient safety incidents reported to the National Patient Safety Agency. Cousins, D., Rosario, C., Scarpello, J.[2021]

A total of 684 adverse drug event reports related to insulin therapy and 84 reports for oral glucose-lowering agents were analyzed from care homes, highlighting a significant risk of harm for older residents with diabetes.

The most frequent errors involved incorrect or unclear dosing, with insulin errors leading to one reported death, indicating a critical need for improved medication management in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes medication patient safety incident reports to the National Reporting and Learning Service: the care home setting. Milligan, FJ., Krentz, AJ., Sinclair, AJ.[2016]

A systematic review of 68 observational studies on non-serious adverse drug events (ADEs) in type 2 diabetes revealed that many studies used inadequate methods for detecting ADEs, with only a third exceeding regulatory requirements for sample size and follow-up duration.

The most effective method for identifying a diverse range of ADEs was solicited surveillance by healthcare professionals, while patient surveys primarily focused on specific issues like hypoglycemia, indicating a need for better methodologies and a combination of approaches to fully capture ADEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients. Hakobyan, L., Haaijer-Ruskamp, FM., de Zeeuw, D., et al.[2022]

A significant increase in unintentional therapeutic errors involving insulin was observed over a 10-year period, with a 495% rise in annual incidence, particularly affecting adults over 40 years old and predominantly women.

Most of these errors occurred in non-healthcare settings, especially during late evening hours, highlighting the need for better management strategies and the importance of poison control centers as a resource for affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unintentional therapeutic errors involving insulin in the ambulatory setting reported to poison centers. Spiller, HA., Borys, DJ., Ryan, ML., et al.[2011]

Over a five-year period, a study of 318 diabetic patients showed an increase in complications, with microvascular issues rising from 33.4% to 42.1% and macrovascular issues from 22.3% to 37.2%, indicating a worsening of overall health despite increased insulin use and self-monitoring.

While some patients experienced a slight reduction in blood pressure, overall management of diabetes was ineffective as HbA1c levels worsened, highlighting the need for improved diabetes care protocols to better control blood sugar levels and reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chronic complications of type 2 diabetes mellitus. Clinical course after 5 years of follow-up]. Mundet Tudurí, X., Carmona Jiménez, F., Gussinyer Canabal, P., et al.[2020]

The quality improvement program significantly enhanced the adherence to diabetes care guidelines among 312 patients, with notable increases in care measures such as blood pressure monitoring (odds ratio of 12.08) and urine albumin testing (odds ratio of 2.43).

Despite improvements in the provision of care, the program did not lead to any measurable benefits in patient outcomes, such as blood pressure or HbA1c levels, over a follow-up period of 42 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of a quality improvement program for patients with type 2 diabetes in general practice. Renders, CM., Valk, GD., Franse, LV., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3033953/

Effectiveness of disease-management programs for ... Our findings suggest that disease-management programs are more effective for patients who have poor glycemic control (mean hemoglobin A1C ≥ 8.0% at baseline) ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/7/1101/158195/The-Diabetes-Prevention-Program-and-Its-Outcomes

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ... After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article-abstract/72/Supplement_1/664-P/150026

664-P: Efficacy of a Digital Diabetes Logbook for Reducing ... Use of mySugr led to a significant improvement in diabetes distress after 3 months compared to the treatment-as-usual control group. Thus, the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8129774/

Effectiveness of diabetes self-management education (DSME ... Based on 15 articles, diabetes self-management education intervention provides significant effectiveness to lifestyle changes and the self-care of T2DM patients ...

5. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1355792/full

Measuring the effectiveness of hybrid diabetes care over ... Results: Case group showed significant HbA1c improvements (-2.19%), especially in higher baseline levels. Weight, BMI, LDL, total cholesterol, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8245208/

The My Diabetes Care Patient Portal Intervention: Usability ... My Diabetes Care (MDC) is a novel, multifaceted patient portal intervention designed to help patients better understand their diabetes health data and support ...

7. professional.diabetes.org professional.diabetes.org/standards-of-care

Standards of Care in Diabetes | ADA Clinical Guidelines Discover the latest ADA diabetes management guidelines, including current diabetes guidelines, clinical practice recommendations, and treatment guidelines ...

8. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S14/157553/1-Improving-Care-and-Promoting-Health-in

1. Improving Care and Promoting Health in Populations Gaps and disparities in diabetes management and outcomes are also prevalent among youth with diabetes in the U.S. Data from SEARCH for Diabetes ...

9. cdc.gov cdc.gov/pcd/issues/2023/22_0210.htm

Using Patient Profiles for Sustained Diabetes Management ... Our objective was to evaluate the association between patient profiles and sustained diabetes management (SDM) among patients with type 2 diabetes.

10. diabetesjournals.org diabetesjournals.org/care

Diabetes Care To promote better patient care by serving the expanded needs of all health professionals committed to the care of patients with diabetes.