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Insulin Delivery Device

MiniMed 780G System for Type 1 Diabetes

N/A
Waitlist Available
Led By Bruce Perkins, MD
Research Sponsored by Medtronic Diabetes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
2 - 6 years of age: A clinical diagnosis of type 1 diabetes for 6 months or more, as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis
Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units and maximum total daily dose of 250 units or less
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new insulin pump in people with type 1 diabetes.

Who is the study for?
This trial is for children and adults aged 2-80 with Type 1 Diabetes who have been using a pump therapy for at least 6 months. Participants must not be planning pregnancy, surgeries requiring general anesthesia during the study, or have untreated celiac disease. They should not have used MiniMed 780G before and must agree to use Fiasp insulin provided by the sponsor.Check my eligibility
What is being tested?
The MiniMed™ 780G System, an advanced insulin delivery system for Type 1 Diabetes management, is being tested with Fiasp® insulin in a home setting across multiple countries to assess its safety and effectiveness in both adult and pediatric subjects.See study design
What are the potential side effects?
Potential side effects may include skin irritation from sensor adhesive, hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), allergic reactions to Fiasp insulin or infusion set issues related to the pump therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 6 years old and have been diagnosed with type 1 diabetes for at least 6 months.
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I use between 8 and 250 units of insulin daily.
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I am between 2 and 80 years old.
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I have been diagnosed with type 1 diabetes.
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I have been using a pump for my condition for over 6 months.
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I can make my own medical decisions.
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I am willing to use Fiasp insulin provided for the study.
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I am between 7 and 80 years old.
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I can make my own medical decisions.
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I am willing to use Fiasp insulin provided for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
Primary Safety Endpoint for Age 18-80 - Change in HbA1c
+1 more
Secondary outcome measures
Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: MiniMed 780G System Utilizing Insulin FiaspExperimental Treatment1 Intervention
Subjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MiniMed 780G System
2022
N/A
~250

Find a Location

Who is running the clinical trial?

Medtronic DiabetesLead Sponsor
67 Previous Clinical Trials
9,686 Total Patients Enrolled
Bruce Perkins, MDPrincipal InvestigatorLeadership Sinai Center for Diabetes
1 Previous Clinical Trials
28 Total Patients Enrolled
Frances Broyles, MDPrincipal InvestigatorRainier Clinical Research Center

Media Library

MiniMed 780G System (Insulin Delivery Device) Clinical Trial Eligibility Overview. Trial Name: NCT05224258 — N/A
Type 1 Diabetes Research Study Groups: MiniMed 780G System Utilizing Insulin Fiasp
Type 1 Diabetes Clinical Trial 2023: MiniMed 780G System Highlights & Side Effects. Trial Name: NCT05224258 — N/A
MiniMed 780G System (Insulin Delivery Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05224258 — N/A
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT05224258 — N/A

Frequently Asked Questions

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

Could minors be included in the parameters of this clinical experiment?

"This research project has a range for enrollment, stipulating that participants must be older than 7 but younger than 80 to qualify."

Answered by AI

How many medical facilities have been approved to administer this experiment?

"Currently, the trial is recruiting from 15 different sites such as Alberta Children's Hospital Research Institute in Calgary, Valley Research in Fresno and Barbara Davis Center for Diabetes in Aurora. An additional dozen medical centres are also included."

Answered by AI

How many individuals are being considered for inclusion in this clinical experiment?

"To carry out the study, 250 suitable candidates must be identified and enrolled. Medtronic Diabetes is organizing this trial from multiple sites including Alberta Children's Hospital Research Institute in Calgary and Valley Research in Fresno, California."

Answered by AI

Does my profile meet the criteria to join this research endeavor?

"This clinical trial is currently accepting 250 participants with a diagnosis of type 1 diabetes, between the ages of two and eighty. To be eligible for enrolment, individuals must meet certain conditions, such as having a minimum daily insulin requirement (Total Daily Dose) above 8 units; being literate in one of the languages offered by the pump system; and consenting to fingerstick blood glucose measurements when necessary. Furthermore, those aged fourteen to eighty are required to have had their medical condition diagnosed at least two years prior, while minors aged seven through thirteen need only demonstrate that they have lived with type 1 diabetes since before turning seven. Finally, any"

Answered by AI

Are there opportunities still available to participate in the trial?

"Per the information provided on clinicaltrials.gov, this is an ongoing trial with a start date of March 17th 2022 and its most recent update occurring on October 26th 2022."

Answered by AI

What objectives are being sought after during this research?

"Within the 3 month trial period, the primary safety outcome to be assessed is a change in HbA1c. Secondary endpoints include evaluating mean percent of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) and hypoglycemia (< 54 mg/dL [3.0 mmol/L]), for both age 7-17 and 18-80 groups respectively, with tests assessing superiority or noninferiority as appropriate."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Florida
How old are they?
18 - 65
65+
What site did they apply to?
University of South Florida
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Want to get better treatment.
PatientReceived no prior treatments
~18 spots leftby Jul 2024