Digital PRO Tool for Type 2 Diabetes

Overseen By Priscilla D'antico

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Renal failure, Psychiatric, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

353 Participants Needed

Trial Summary

What is the purpose of this trial?

Investigators will conduct a hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) to evaluate the effectiveness of iMatter2 versus usual care on reduction in HbA1c at 12-months (primary outcome) among patients with Type 2 diabetes (T2D).

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is the Digital PRO Tool for Type 2 Diabetes safe for humans?

The research articles provided do not contain specific safety data for the Digital PRO Tool or iMatter2. They focus on the safety of various diabetes medications, but not on digital tools or platforms. ^{1 2 3 4 5}

How does the treatment iMatter2 for Type 2 Diabetes differ from other treatments?

iMatter2 is a digital tool designed to help manage Type 2 Diabetes by providing personalized support and data analysis, which is different from traditional treatments that primarily focus on medication and lifestyle changes. This tool leverages technology to offer real-time insights and decision support, potentially improving diabetes management by making it easier for patients to track and adjust their treatment plans. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment iMatter2 for type 2 diabetes?

Research shows that digital tools, like smartphone-based systems, can help people with type 2 diabetes manage their condition by monitoring glucose, diet, and activity, which may suggest that iMatter2 could be effective in a similar way. ^{11 12 13 14 15}

Research Team

Antoinette Schoenthaler, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

Adults over 18 with Type 2 diabetes for at least 6 months, who are fluent in English or Spanish, can text, and have a history of high HbA1c levels. Excluded are those planning to leave their clinic soon, unable to consent, with significant mental health or substance issues, pregnant women, participants in other diabetes studies, or patients with severe kidney problems.

Inclusion Criteria

I have been diagnosed with type 2 diabetes for at least 6 months.

PCP Group: Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers or faculty group practices and provide care to at least five patients with a diagnosis of T2D

My type 2 diabetes is uncontrolled with HbA1c over 7% in the last year.

Exclusion Criteria

You have a serious mental health condition or a history of substance abuse.

Patient Group: Plan to discontinue care at the clinic within the next 12 months

Patient Group: Are pregnant or planning to become pregnant within 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the iMatter2 intervention or usual care for diabetes management

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• iMatter2

Trial Overview The trial is testing iMatter2—a mobile tool for reporting patient outcomes—against usual care to see if it better reduces long-term blood sugar levels (HbA1c) in people with Type 2 diabetes after one year.

Participant Groups

Group I: iMatter2 Experimental Treatment 1 Intervention

All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2.

Group II: Usual Care (UC) Active Control 1 Intervention

All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Findings from Research

The smartphone-based mDiabetes system significantly reduced HbA1c levels in patients with type 2 diabetes by an average of 0.40%, compared to only 0.06% in the traditional paper logbook group, over a 24-week trial involving 172 participants.

Patients using mDiabetes were more likely to achieve HbA1c levels below 7.0% without experiencing hypoglycemia, indicating that this digital intervention is both effective and safe for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. Kim, EK., Kwak, SH., Jung, HS., et al.[2022]

Incretin-based therapies, including GLP-1 receptor agonists and DPP-4 inhibitors, effectively lower blood sugar levels in type 2 diabetes while also improving beta-cell function, blood pressure, and lipid levels, with a low risk of causing hypoglycemia.

GLP-1 receptor agonists are associated with weight loss, whereas DPP-4 inhibitors are weight neutral, highlighting important differences in their clinical profiles for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of incretin based therapies: clinical trial data. White, J.[2022]

A study analyzing FDA Adverse Event Reporting System data from January 2013 to March 2022 found that different DPP-4 inhibitors have varying risks for serious side effects, such as acute kidney injury and pemphigoid, which can guide treatment choices for diabetes patients.

Specifically, alogliptin showed a significantly lower risk of acute kidney injury compared to sitagliptin, but a higher risk of pemphigoid, highlighting the importance of selecting the appropriate DPP-4 inhibitor based on a patient's specific health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System. Ogura, T., Shiraishi, C.[2023]

Empagliflozin has been shown to effectively improve glycemic control in patients with type 2 diabetes, with a mean decrease in HbA1c of 0.4% and an increase in the proportion of patients achieving HbA1c <6.5% after six months of treatment.

The safety profile of empagliflozin is favorable, as there were no significant increases in severe hypoglycemia or cases of diabetic ketoacidosis, indicating it can be safely used in a broader range of patients, often in combination with other diabetes medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany. Bramlage, P., Tittel, SR., Wagner, C., et al.[2021]

The review highlights that while there are many innovative drugs being developed for type 2 diabetes, several have faced serious safety issues, leading to their withdrawal or halting of development.

It discusses the current state of treatments, including glitazones, incretin mimetics, SGLT-2 inhibitors, and new experimental drugs, emphasizing the need for better methods to predict and differentiate drug-related adverse events from natural disease occurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Benefits and risks of current pharmacotherapy in the treatment of type 2 diabetes]. Schindler, C., Barthel, A., Fischer, S., et al.[2021]

In a study involving liraglutide users followed for a median of 15 months, the incidence rate of acute pancreatitis was slightly higher (187.5 cases per 100,000 person-years) compared to other non-GLP-1 therapies, but this difference was not statistically significant (adjusted RR 1.10).

For pancreatic cancer, liraglutide showed a lower incidence rate (19.9 cases per 100,000 person-years) compared to non-GLP-1 therapies (33.0 cases), suggesting no increased risk associated with liraglutide (adjusted RR 0.65).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, claims-based assessment of the risk of pancreatitis and pancreatic cancer with liraglutide compared to other antidiabetic drugs. Funch, D., Gydesen, H., Tornøe, K., et al.[2021]

The Diabesdagboga smartphone app and Diani web portal allow for comprehensive tracking of diabetes-related data, including blood sugar levels, carbohydrate intake, insulin doses, and physical activity, enhancing patient engagement and data analysis.

A case report of a patient using this system for nearly two years showed a significant improvement in metabolic control, with an 18.6 mmol/mol decrease in HbA1c, indicating better long-term blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term use of the telemonitoring system Diani in the therapy of a patient with type 1 diabetes. Brož, J., Holubová, A., Mužík, J., et al.[2022]

References

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

The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. [2022]

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

Prototype of an evidence-based tool to aid individualized treatment for type 2 diabetes. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a digital tool supporting therapeutic decision making for the personalized management of patients with type 2 diabetes not treated with insulin: A pilot study. [2023]

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

Use of the GlucoWatch biographer in children with type 1 diabetes. [2022]

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

Effect of computer-generated tailored feedback on glycemic control in people with diabetes in the community: a randomized controlled trial. [2022]

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

Efficacy and safety of incretin based therapies: clinical trial data. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System. [2023]

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

The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Benefits and risks of current pharmacotherapy in the treatment of type 2 diabetes]. [2021]

10. England pubmed.ncbi.nlm.nih.gov

A prospective, claims-based assessment of the risk of pancreatitis and pancreatic cancer with liraglutide compared to other antidiabetic drugs. [2021]

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

A wireless diabetes management and communication system. [2011]

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

The Reference Guide to Integrate Smart Insulin Pens Into Data-Driven Diabetes Care and Education Services. [2021]

13. Israel pubmed.ncbi.nlm.nih.gov

Decision Support Systems for Insulin Treatment Adjustment in People with Type 1 Diabetes. [2020]

14. Czech Republic pubmed.ncbi.nlm.nih.gov

Long term use of the telemonitoring system Diani in the therapy of a patient with type 1 diabetes. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot trial of a hand-held patient-oriented, insulin regimen optimizer. [2019]