My Diabetes Care for Diabetes

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

458 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment My Diabetes Care for diabetes?

The research highlights the importance of patient-reported outcomes and quality improvement programs in diabetes care, suggesting that treatments like My Diabetes Care, which focus on enhancing patient engagement and care quality, can improve health outcomes for people with diabetes. ^{1 2 3 4 5}

What safety data exists for My Diabetes Care treatment?

The research articles focus on the safety of diabetes treatments, particularly insulin, highlighting frequent patient safety incidents and adverse drug events. These studies emphasize the need for better monitoring and educational interventions to prevent drug-related complications in diabetic patients. ^{6 7 8 9 10}

How does the treatment My Diabetes Care differ from other diabetes treatments?

My Diabetes Care is unique because it is a web-based, interactive tool that focuses on patient-centered goal-setting and shared decision-making with healthcare teams, rather than just medication or lifestyle changes. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care (MDC), to evaluate its effect on clinical outcomes.

Research Team

William Martinez, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Ireland 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of a quality improvement program for patients with type 2 diabetes in general practice. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Preparing for success: redesigning the diabetes office practice. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Can the Routine Use of Patient-Reported Outcome Measures Improve the Delivery of Person-Centered Diabetes Care? A Review of Recent Developments and a Case Study. [2020]

5. Spain pubmed.ncbi.nlm.nih.gov

[Chronic complications of type 2 diabetes mellitus. Clinical course after 5 years of follow-up]. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Safety during the monitoring of diabetic patients: trial teaching course on health professionals and diabetics - SEGUDIAB study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Insulin, hospitals and harm: a review of patient safety incidents reported to the National Patient Safety Agency. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Diabetes medication patient safety incident reports to the National Reporting and Learning Service: the care home setting. [2016]

9. England 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Unintentional therapeutic errors involving insulin in the ambulatory setting reported to poison centers. [2011]

11. England pubmed.ncbi.nlm.nih.gov

Integrating shared decision-making into primary care: lessons learned from a multi-centre feasibility randomized controlled trial. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Patients' perspectives on how to improve diabetes care and self-management: qualitative study. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Metabolic control and amputations among diabetics in primary health care--a population-based intensified programme governed by patient education. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Self-care habits and disease-state understanding of diabetic patients. [2011]

15. Japan pubmed.ncbi.nlm.nih.gov

[A diabetes care team--role of diabetes specialists and certified diabetes educator]. [2009]