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Device

Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app for Type 1 Diabetes

N/A
Waitlist Available
Research Sponsored by Medtronic Diabetes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months
Awards & highlights

Study Summary

This trial is testing a new diabetes management system that collects data on insulin, sleep, activity, and diet. It will last for at least 90 days and up to 9 months, and may include optional recording of insulin injections and/or menstrual cycles, and/or cardiac activity.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Time in Range

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

Trial Design

1Treatment groups
Experimental Treatment
Group I: Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pensExperimental Treatment1 Intervention
All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app
2021
N/A
~220

Find a Location

Who is running the clinical trial?

Medtronic DiabetesLead Sponsor
67 Previous Clinical Trials
9,709 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this analysis restricted to participants aged seventy-five and under?

"According to the eligibility criteria, this study has a minimum age of participation set at two years old and an upper limit of 80."

Answered by AI

What are the eligibility criteria for enrollment in this trial?

"This study seeks to recruit 500 people with type 1 diabetes mellitus aged between 2 and 80."

Answered by AI

Is recruitment for this medical experiment open at present?

"As per the information available on clinicaltrials.gov, this experiment is actively seeking participants. It was initially posted on April 6th 2021 and recently modified on November 22nd 2022."

Answered by AI

How many participants are being recruited for this experiment?

"This clinical trial requires 500 eligible patients to partake, who can register at Endocrine and Metabolic Consultants in Rockville, Maryland or Rhode island Hospital (Lifespan Clinical Research Center) in Providence."

Answered by AI

How many sites are participating in the execution of this experiment?

"This trial has 11 clinical sites in total, three of which are Endocrine and Metabolic Consultants in Rockville, Maryland; Rhode island Hospital (Lifespan Clinical Research Center) in Providence, Rhode Island; and Rocky Mountain Diabetes and Osteoporosis Center in Idaho Falls, Idaho."

Answered by AI

Who else is applying?

What state do they live in?
Other
Georgia
California
Texas
How old are they?
18 - 65
What site did they apply to?
Barbara Davis Center for Childhood Diabetes
Texas Diabetes and Endocrinology
Other
Atlanta Diabetes Associates
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Better treatment with no side effects. I have always been curious about Guardian.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Atlanta Diabetes Associates: < 48 hours
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Use of the Guardian™ Connect System With Smart Connected Devices
2021. "Use of the Guardian™ Connect System With Smart Connected Devices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04809285.
~54 spots leftby Apr 2025
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