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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool, iMatter2, to determine if it helps people with Type 2 diabetes manage their condition better than usual care. Researchers aim to discover if this tool can lower blood sugar levels over 12 months. Individuals who have had Type 2 diabetes for at least six months, struggle with control, and are comfortable using text messages may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management solutions.

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.

What prior data suggests that the iMatter2 tool is safe for patients with Type 2 diabetes?

Studies have shown that iMatter2, a digital tool for managing Type 2 diabetes, is easy to use and safe. Although specific safety data from research articles is lacking, the tool functions as a mobile health app. Users do not need to take medication or undergo medical procedures, which typically reduces the risk of side effects.

Research has examined the tool's usability and effectiveness in managing diabetes. As a digital tool, the primary focus is on its ease of use and its utility in tracking health.

Overall, using a digital tool like iMatter2 is generally safe because it primarily involves an app on a mobile device. Users should follow the app's instructions and consult their healthcare providers about managing their diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital PRO Tool, iMatter2, because it offers a fresh approach to managing Type 2 diabetes. Unlike standard treatments that focus on medication and diet management, this tool aims to enhance patient engagement through digital means. By involving patients more actively in their care, iMatter2 could lead to better health outcomes and more personalized treatment strategies. This innovative tool may transform how patients interact with their healthcare, making it a promising addition to current diabetes management options.

What evidence suggests that the iMatter2 tool is effective for Type 2 diabetes?

Research shows that iMatter2, a digital tool tested in this trial, helps manage Type 2 Diabetes by providing personalized support through text messages and journal updates. Previous studies have found that similar mobile health tools effectively incorporate patient feedback into diabetes care, potentially leading to better health outcomes. In this trial, participants in the iMatter2 arm will use the tool, which specifically aims to lower HbA1c levels, a crucial measure of blood sugar control, over 12 months. This tool is designed to help patients maintain healthier blood sugar levels, essential for managing Type 2 Diabetes. Early signs suggest that iMatter2 could benefit those seeking to improve their diabetes management. ^{2 3 6 7 8}

Who Is on the Research Team?

Antoinette Schoenthaler, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

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iMatter2 Study | NYU Langone Health Connected2Care's iMatter2 study at NYU Langone uses text messaging and journal reports to help patients with type 2 diabetes manage their health.

2. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/imatter2-ai-driven-approach-supercharge-novel-digital-patient-reported

iMatter2 - An AI-Driven Approach to Supercharge a Novel ... They will then conduct a randomized clinical trial to evaluate the effectiveness of iMatter2 versus usual care on HbA1c reduction at 12 months among 353 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03652389?tab=results

i-Matter: Investigating an mHealth Texting ... i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management · Results Overview · Study Record Dates · Participant ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7490676/

Investigation of a Mobile Health Texting Tool for ... The i-Matter (investigating an mHealth texting tool for embedding patient-reported data into diabetes management) trial aims to address this gap in the ...

5. withpower.com withpower.com/trial/digital-pro-tool-for-type-2-diabetes-ed970

Digital PRO Tool for Type 2 Diabetes · Info for Participants iMatter2 is a digital tool designed to help manage Type 2 Diabetes by providing personalized support and data analysis, which is different from traditional ...

6. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/imatter2-ai-driven-approach-supercharge-novel-digital-patient-reported/citation/opening

Opening the black box of an mHealth patient-reported outcome tool ... Opening The Black Box of An MHealth Patient-reported Outcome Tool For Diabetes Self-management: Interview Study Among Patients With Type 2 Diabetes.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03652389

Study Details | NCT03652389 | i-Matter: Investigating an ... ... Tool for Embedding Patient-reported Data Into Diabetes Management ... Analyzing User Engagement Within a Patient-Reported Outcomes Texting Tool for Diabetes ...

8. digital.ahrq.gov digital.ahrq.gov/medical-condition/diabetes-mellitus?page=1

Diabetes Mellitus | Digital Healthcare Research Opening the black box of an mHealth patient-reported outcome tool for diabetes self-management: Interview study among patients with type 2 diabetes. Citation.