Smart Insulin Pens for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if Smart Insulin Pens (SIPs) outperform traditional insulin pens for people with diabetes. The focus is on enhancing blood sugar control and health outcomes by using SIPs with continuous glucose monitors (CGMs) and telemedicine. It compares two groups: one using the new SIPs and another using traditional pens. Ideal participants are those who have used multiple daily insulin shots for at least three months. As an unphased trial, this study allows participants to contribute to innovative diabetes care solutions.
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 prior data suggests that Smart Insulin Pens are safe for managing diabetes?
Research has shown that the InPen Smart insulin pen is safe for use. The FDA approved it for managing diabetes, indicating it meets strict safety standards. Users have not reported any unusual safety problems. This device aids those with diabetes by delivering insulin accurately and assisting with dose calculations. The InPen is easy to use and integrates well with other diabetes management tools, such as glucose monitors. Overall, the InPen is well-tolerated, with no major side effects reported.12345
Why are researchers excited about this trial?
Researchers are excited about the InPen Smart insulin pen because it offers a high-tech approach to managing diabetes. Unlike traditional insulin pens, which require manual tracking, the InPen automatically records insulin doses and syncs this data with a smartphone app. This integration provides real-time insulin tracking and personalized insights, aiming to make diabetes management more precise and less burdensome for patients. By combining telehealth with smart technology, this treatment could significantly enhance patient engagement and improve blood sugar control.
What evidence suggests that the InPen Smart insulin pen is effective for managing diabetes?
Research has shown that the InPen Smart insulin pen, which participants in this trial may use, helps people with diabetes manage their blood sugar more effectively. Studies have found that using InPen leads to more stable blood sugar levels. The pen reminds users to take their insulin, which has been linked to better treatment outcomes. In everyday use, people with InPen have taken more bolus insulin (extra insulin at meal times) and achieved better overall control of their diabetes. This smart pen simplifies daily insulin decisions and improves communication with healthcare providers.678910
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on changes in hyperglycemia and HbA1c levels
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Intervention group: will be managed with telehealth and InPen Smart insulin pens
Control group: will be managed by telehealth and the traditional/standard insulin pen (widely used)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Medtronic
Industry Sponsor
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
Citations
Real-World Evidence of the InPen Smart Insulin Pen
It demonstrates that smart insulin pen systems support MDI therapy patients in daily dosing decisions and may facilitate communication with the diabetes care ...
2.
news.medtronic.com
news.medtronic.com/InPen-TM-Smart-Insulin-Pen-data-shows-the-systems-unique-reminders-improve-treatment-outcomes-for-those-using-multiple-daily-injectionsInPen™ Smart Insulin Pen data shows the system's unique ...
InPen™ Smart Insulin Pen data shows the system's unique reminders improve treatment outcomes for those using multiple daily injections ; TIR. 52%.
3.
diabetesjournals.org
diabetesjournals.org/diabetes/article/70/Supplement_1/219-OR/139799/219-OR-Impact-Of-Inpen-Smart-Insulin-Pen-Use-on219-OR: Impact Of Inpen Smart Insulin Pen Use on Real ...
These data show that InPen use is associated with improved glycemic control and increased doses of bolus insulin in users with poor glycemic control.
Insights into the effective use of the Smart MDI system
The study analysed real-world data of people with type 1 diabetes (PWT1D) using the Smart Multiple Daily Insulin (MDI) system with the aim of ...
Medtronic reports first real-world data on smart insulin pen ...
According to a news release, less than 30% of people with diabetes using CGM achieve the glycemic target of HbA1c < 7%. Studies show that MDI, ...
InPen™ Smart Insulin Pen
Safety Information The InPen is a reusable insulin pen for people living with diabetes. It can be used to deliver insulin, help calculate insulin doses, and ...
7.
medtronic.com
medtronic.com/en-us/healthcare-professionals/products/diabetes/smart-insulin-products/inpen-smart-insulin-pen.htmlInPen™ Smart Insulin Pen
Integrated, reliable diabetes data. InPen™ Insights Reports provide a way to view a patient's glucose, carbohydrate, and insulin dosing data from their InPen ...
8.
molinamarketplace.com
molinamarketplace.com/marketplace/wa/en-us/Providers/-/media/77B362002BE841F1A79B2903B8DBB043.ashxInPen (insulin smart pen) C29696-A
On June 18th, 2020, the FDA approved Companion Medical's InPen for the management of diabetes. It is now approved with the expanded indication ...
Insulin and Medicine Devices for Diabetes l InPen
The first FDA-cleared Smart Insulin Pen (SIP), InPen offers dosing support with the convenience and low cost of an insulin pen paired to an integrated ...
Important Safety Information
Important safety information. Indications, contraindications, warnings and precautions. All Medtronic MiniMed™ devices and associated ...
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