Electronic Prompts for Type 2 Diabetes

(DEPICCT Trial)

Overseen By Paul Peng, MD PhD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Diabetic ketoacidosis, Diabetic foot ulcer, others

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

Compensation: Varies

Number of Visits: 2

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to improve the processes of Type 2 Diabetes (T2D) care coordination and treatment in the emergency department (ED) by utilizing clinical decision support mechanisms in the electronic health record (EHR). The main question is whether electronic prompts triggered by hyperglycemia and elevated A1c results in providers providing earlier treatments and faster time to subsequent primary care appointment and greater reduction in hemoglobin A1c (HA1c). ED clinicians will receive alerts called Our Practice Advisories (OPA's) through the EPIC EHR. The 1st OPA triggers when a random point-of-care (POC) glucose is ≥250 mg/dL, prompting a suggested additional HA1c order. A 2nd OPA triggers if the resulting HA1c is ≥10%, prompting consideration of further care coordination in the Observation Unit. Investigators will compare the outcomes post-intervention compared to pre-intervention.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Diabetes Electronic Prompt?

Research shows that automated and mobile health prompts, like text messages, can help people with diabetes remember to get important tests and support behavior changes needed to manage their condition. These prompts are convenient and cost-effective, making them a useful tool in diabetes care. ^{1 2 3 4 5}

Is the Electronic Prompt for Type 2 Diabetes safe for humans?

The safety of diabetes technologies, including electronic prompts, is generally well-established, but there are concerns about adverse events (unintended negative effects) related to diabetes devices, which have increased in recent years. User error is a common cause of these events, highlighting the importance of proper use and monitoring. ^{6 7 8 9 10}

How does the electronic prompts treatment for type 2 diabetes differ from other treatments?

Electronic prompts for type 2 diabetes are unique because they use mobile health (mHealth) technology, like text messages and push notifications, to encourage behavior changes and improve self-management. This approach is different from traditional treatments as it focuses on enhancing patient engagement and compliance through digital reminders, rather than relying solely on medication or in-person interventions. ^{1 2 4 5 11}

Eligibility Criteria

This trial is for individuals with Type 1 or Type 2 Diabetes who visit the emergency department. It's designed to see if electronic prompts in the hospital's record system can help doctors spot and treat high blood sugar faster.

Inclusion Criteria

Moderate hyperglycemia (glucose ≥250 mg/dL)

Patients who arrive in the emergency department

Not pregnant or peri-partum

Exclusion Criteria

Diabetic ketoacidosis (pH < 7.20, HCO3 < 15, AG > 25)

Patients who leave against medical advice (AMA), elope from the ED, or are transferred to another facility

I have a diabetic foot ulcer or skin issues due to diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Intervention

ED providers receive electronic alerts to improve care coordination and treatment for T2D patients

Ongoing during ED encounter

1 visit (in-person)

Follow-up

Participants are monitored for follow-up care coordination and reduction in HbA1c levels

4 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Diabetes Electronic Prompt

Trial Overview The study tests whether alerts (OPAs) for high glucose levels lead to quicker additional testing, better care coordination, and improved diabetes control. One alert suggests more tests when glucose is very high; another recommends extra care steps if A1c is extremely elevated.

Participant Groups

Group I: Intervention Experimental Treatment 2 Interventions

All ED providers exposed to electronic alerts

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Findings from Research

Mobile health (mHealth) prompts, especially text messaging, are widely used in diabetes prevention programs, but their effectiveness on behavior change and diabetes incidence shows mixed results based on a review of 44 studies.

Participants generally received mHealth prompts positively, yet there is a lack of clarity on the theoretical basis for prompt design and timing, indicating a need for more rigorous research to optimize these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth prompts within diabetes prevention programs: a scoping review. MacPherson, MM., Merry, KJ., Locke, SR., et al.[2022]

A study involving 549 participants from the TuDiabetes.org online community found that 75 reported device-related adverse events, with nearly half requiring intervention, highlighting the potential for online networks to capture real-world device issues.

Only 4% of these adverse events were reported to the FDA, suggesting that online participatory surveillance can provide more comprehensive outcome data compared to traditional reporting methods, which often lack detailed information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. Mandl, KD., McNabb, M., Marks, N., et al.[2021]

A significant 86% of the 111 diabetes patients experienced at least one adverse event (AE) or potential adverse event (PotAE) over a 9-month period, highlighting the prevalence of safety issues in chronic disease management.

The majority of AEs (63%) were related to medication management, and 77% of events involved patient actions, indicating that enhancing patient self-management and communication with healthcare providers is crucial for preventing these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What happens between visits? Adverse and potential adverse events among a low-income, urban, ambulatory population with diabetes. Sarkar, U., Handley, MA., Gupta, R., et al.[2021]

References

1. China pubmed.ncbi.nlm.nih.gov

mHealth prompts within diabetes prevention programs: a scoping review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Patient attitudes toward using computers to improve health services delivery. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The effect of a patient-oriented treatment decision aid for risk factor management in patients with diabetes (PORTDA-diab): study protocol for a randomised controlled trial. [2021]

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

Automated messaging to improve compliance with diabetes test monitoring. [2009]

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

Computerized prompting and feedback of diabetes care: a review of the literature. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Longitudinal Assessment of the Quality of Insulin Prescribing with Different Prescribing Systems. [2021]

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

Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. [2021]

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

What happens between visits? Adverse and potential adverse events among a low-income, urban, ambulatory population with diabetes. [2021]

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

Health Care Professionals' Perspectives on Use of Diabetes Technologies for Managing Visually Impaired Patients With Diabetes. [2023]

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

More Focus is Needed to Reduce Adverse Events for Diabetes Devices. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Promoting Engagement With a Digital Health Intervention (HeLP-Diabetes) Using Email and Text Message Prompts: Mixed-Methods Study. [2022]