MiniMed 780G System for Type 1 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Type 1 Diabetes Mellitus+1 More
MiniMed 780G System - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the safety of using Lyumjev insulin lispro to treat type 1 diabetes in children and adults at home.

Eligible Conditions
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Study Objectives

6 Primary · 6 Secondary · Reporting Duration: 3 months

3 months
Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
Primary Effectiveness Endpoint for Age 2-17 - Percent of Time in Range (TIR 70-180 mg/dL)
Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)
Primary Safety Endpoint for Age 18-80 - Change in HbA1c
Primary Safety Endpoint for Age 2-17 - Change in HbA1c
Primary Safety Endpoint for Age 7-17 - Change in HbA1c
Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Secondary Effectiveness Endpoint 1 for Age 2-17 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Hypoglycemia
Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
Secondary Effectiveness Endpoint 2 for Age 2-17 - Percent of Time in Range (TIR 70-180 mg/dL)
Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)

Trial Safety

Trial Design

1 Treatment Group

MiniMed 780G System Utilizing Insulin Lyumjev®
1 of 1

Experimental Treatment

250 Total Participants · 1 Treatment Group

Primary Treatment: MiniMed 780G System · No Placebo Group · N/A

MiniMed 780G System Utilizing Insulin Lyumjev®
Device
Experimental Group · 1 Intervention: MiniMed 780G System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

Medtronic DiabetesLead Sponsor
66 Previous Clinical Trials
9,524 Total Patients Enrolled
42 Trials studying Type 1 Diabetes Mellitus
5,873 Patients Enrolled for Type 1 Diabetes Mellitus
Eli Lilly and CompanyIndustry Sponsor
2,455 Previous Clinical Trials
3,120,536 Total Patients Enrolled
33 Trials studying Type 1 Diabetes Mellitus
6,265 Patients Enrolled for Type 1 Diabetes Mellitus

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You do not have a legally authorized representative to consent on your behalf due to mental or intellectual disability.
You are willing to participate in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
North Carolina50.0%
Georgia50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Atlanta Diabetes50.0%
Physicians East50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%