Smart Insulin Pens for Diabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: MDI insulin

Must not be taking: Hydroxyurea, Chronic acetaminophen

Disqualifiers: Pregnancy, Dialysis, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it seems you need to have been on MDI insulin for at least 3 months before joining. If you recently started or changed non-insulin diabetes medications within 60 days, you might not be eligible.

What data supports the effectiveness of the treatment InPen Smart insulin pen for diabetes?

Research shows that the InPen Smart insulin pen, when used with continuous glucose monitoring, helps people with diabetes improve their blood sugar control by reducing missed doses and providing accurate dosing advice. This smart pen system offers features like dose tracking and reminders, which can lead to better diabetes management and improved health outcomes. ^{1 2 3 4 5}

Is the InPen Smart Insulin Pen safe for use in humans?

The InPen Smart Insulin Pen has been studied in real-world settings and is generally considered safe for use in managing diabetes, although there was a report of a malfunctioning insulin pen device causing issues in one case. Overall, the technology aims to improve insulin delivery and reduce dosing errors, which can enhance safety. ^{1 2 3 6 7}

How is the InPen Smart insulin pen treatment different from other diabetes treatments?

The InPen Smart insulin pen is unique because it connects to a mobile app via Bluetooth, allowing users to track insulin doses, receive dosing advice, and set reminders, which helps improve adherence and accuracy compared to traditional insulin pens or syringes. ^{1 2 3 4 5}

What is the purpose of this trial?

Almost 40% of veterans have diabetes, the proposed research may improve clinical care among veterans with diabetes. In this application we are going to examine whether utilizing Smart Insulin pens (SIPs) with CGMs and telemedicine is a better tool for managing diabetes compared to traditional insulin pens, CGMs and telemedicine, leading to improved blood sugar control and better clinical outcomes.

Eligibility Criteria

This trial is for veterans with diabetes who are currently using insulin pens and CGMs (continuous glucose monitors). It's designed to see if Smart Insulin Pens, combined with telemedicine, can better manage their condition compared to traditional methods.

Inclusion Criteria

I have been using insulin injections for at least 3 months.

Exclusion Criteria

I started or changed my diabetes medication less than 60 days ago.

I have diabetes and haven't used multiple daily insulin injections for the last 3 months.

Patients with DM at the time of screening on insulin pumps

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either the intervention group using Smart Insulin Pens (SIPs) and telemedicine or the control group using traditional insulin pens and telemedicine

12 weeks

Telemedicine visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on changes in hyperglycemia and HbA1c levels

4 weeks

Treatment Details

Interventions

• InPen Smart insulin pen

Trial Overview The study compares the effectiveness of InPen Smart insulin pens versus traditional insulin pens in managing diabetes. Both groups will use CGMs and telemedicine to monitor their condition, aiming for improved glycemic control.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Intervention group: will be managed with telehealth and InPen Smart insulin pens

Group II: Control Group Experimental Treatment 1 Intervention

Control group: will be managed by telehealth and the traditional/standard insulin pen (widely used)

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

References

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

Shining the Spotlight on Multiple Daily Insulin Therapy: Real-World Evidence of the InPen Smart Insulin Pen. [2023]

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

Efficacy of a Smart Insulin Pen Cap for the Management of Patients with Uncontrolled Type 2 Diabetes: A Randomized Cross-Over Trial. [2023]

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

A novel pen-based Bluetooth-enabled insulin delivery system with insulin dose tracking and advice. [2018]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Insulin delivery using pen devices. Simple-to-use tools may help young and old alike. [2016]

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

Severe deterioration of metabolic control caused by malfunction of a disposable insulin pen device. [2011]

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

Increased Time in Range and Fewer Missed Bolus Injections After Introduction of a Smart Connected Insulin Pen. [2021]