Type 1 DiabetesNCT05325294

Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev®

A study testing MiniMed 780G System in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This US study will evaluate the safety and effectiveness of utilizing insulin Lyumjev® lispro-aabc in the MiniMed™ 780G System in Type 1 adult and pediatric subjects in a home setting to support product and system labeling. Read more about this study

Who is it for?: Ages 7 to 80 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: MiniMed 780G System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 244 participants
Where: 19 sitesUnited States
Study dates: 5 May 2022to 3 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age 7-80 years at time of screening.
Has a clinical diagnosis of type 1 diabetes:
14-80 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
7-13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials.

Show all 20Show fewer

Subject and/or legally authorized representative is willing to provide informed consent for participation.
Is willing to perform fingerstick blood glucose measurements as needed.
Is willing to wear the system continuously throughout the study.
Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units and a maximum total daily dose of 250 units or less.
Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
Note: All HbA1c blood specimens will be sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range, the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range.
Uses pump therapy for greater than 6 months (with or without CGM experience) prior to screening
Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.
Is willing to take one of the following insulins and can financially support the use of insulin preparations as required during the run-in period:
Humalog (insulin lispro injection)
NovoLog (insulin aspart injection)
Admelog(insulin lispro injection)
Is willing to take Lyumjev insulin during the study period (supplied via Sponsor).

Who cannot join

Has hypersensitivity to insulin lispro or one of the excipients in Lyumjev®
Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)
Coma
Seizures
Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.

Show all 45Show fewer

Has had DKA in the last 6 months prior to screening visit.
Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
Is female of child-bearing potential and result of pregnancy test is positive at screening.
Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
Is female and plans to become pregnant during the course of the study
Is being treated for hyperthyroidism at time of screening.
Has diagnosis of adrenal insufficiency.
Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoid during the course of the study.
Is using hydroxyurea at time of screening or plans to use it during the study.
Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
Is currently abusing illicit drugs.
Is currently abusing marijuana.
Is currently abusing prescription drugs.
Is currently abusing alcohol.
Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
Has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
Has elective surgery planned that requires general anesthesia during the course of the study.
Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
Is diagnosed with current eating disorder such as anorexia or bulimia.
Has been diagnosed with chronic kidney disease that results in chronic anemia.
Has a hematocrit that is below the normal reference range of lab used.
Is on dialysis.
Has serum creatinine of >2 mg/dL.
Has celiac disease that is not adequately treated as determined by the investigator.
Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
Has had history of cardiovascular event 1 year or more from the time of screening without
a normal EKG and stress test within 6 months prior to screening or during screening or
clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test.
Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to screening or during screening or clearance from a qualified physician if there is an abnormal EKG:
Age >35 years
Type 1 diabetes of >15 years' duration
Presence of any additional risk factor for coronary artery disease
Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
Presence of peripheral vascular disease
Presence of autonomic neuropathy
Is a member of the research staff involved with the study.
Has used a MiniMed 780G pump prior to screening

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Atlanta Diabetes
Atlanta, Georgia, 30318
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Barbara Davis Center
Aurora, Colorado, 80045
Texas Diabetes
Austin, Texas, 78749
Barry J Reiner MD LLC
Baltimore, Maryland, 21229
Physicians East
Greenville, North Carolina, 27834
Rocky Mountain
Idaho Falls, Idaho, 83404
East Coast Institute for Research (Memorial Hospital)
Jacksonville, Florida, 32204
The Docs LLC
Las Vegas, Nevada, 89113
East Coast Institute for Research - Macon
Macon, Georgia, 31210
Yale University
New Haven, Connecticut, 06511
Stanford University
Palo Alto, California, 94304
Rainier Research
Renton, Washington, 98057
Mayo Clinic
Rochester, Minnesota, 55905
Endocrine Research Solutions
Roswell, Georgia, 30076
International Diabetes Center
Saint Louis Park, Minnesota, 55416
Diabetes and Glandular Disease Clinic, P.A
San Antonio, Texas, 78229
Rady Children's Hospital San Diego
San Diego, California, 92123
University of South Florida Diabetes Center
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects Utilizing Lyumjev® Insulin Lispro-aabc

Read the detailed description

This study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes on the MiniMed™ 780G system using Lyumjev® insulin lispro-aabc and Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long.

A total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be enrolled at up to 25 investigational centers across the United States in order to have at least 200 subjects enter the study period. Up to 125 subjects will be enrolled in the pediatric age group (7-17 years of age) and up to 125 in the adult age group (18 years or older).

Conditions: Type 1 Diabetes
Being tested: MiniMed 780G System
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MiniMed 780G SystemDevice
MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc

Study groups in NCT05325294
Study group	Role	What they receive
MiniMed 780G System Utilizing Insulin Lyumjev®	Experimental	Subjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months. Receives: Device: MiniMed 780G System

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Safety Endpoint - Change in HbA1c
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Measured: 3 months
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL)
The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Measured: Last 6-7 weeks of 3 month study period

Secondary outcomes (2)

Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL)
The mean % of time in hypoglycemia (< 54 mg/dL). Non-inferiority test.
Measured: Last 6-7 weeks of 3 month study period
Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL)
The mean % of time in range (TIR 70-180 mg/dL). Superiority test.
Measured: Last 6-7 weeks of 3 month study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 20223 Jan 2024

First posted13 Apr 2022
Study start5 May 2022
Primary completion3 Jan 2024
Study completion3 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05325294
Sponsor's protocol ID: CIP335
Status last verified: Dec 2024
First submitted: 5 Apr 2022
Last updated: 15 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects Utilizing Lyumjev® Insulin Lispro-aabc
ClinicalTrials.gov ID: NCT05325294
Acronym / sponsor ID: CIP335
Conditions: Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 244 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 5 May 2022 (actual)
Primary completion: 3 Jan 2024 (actual)
Study completion: 3 Jan 2024 (actual)
First posted: 13 Apr 2022 (actual)
Results: Posted 15 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MiniMed 780G System Utilizing Insulin Lyumjev®	Experimental	Device: MiniMed 780G SystemSubjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.

Who may qualify

Ages: 7 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (20 listed)

Age 7-80 years at time of screening.
Has a clinical diagnosis of type 1 diabetes:
Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials.
Subject and/or legally authorized representative is willing to provide informed consent for participation.

Key exclusion criteria (45 listed)

Has hypersensitivity to insulin lispro or one of the excipients in Lyumjev®
Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
Has had DKA in the last 6 months prior to screening visit.
Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MiniMed 780G SystemMiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc	Device	MiniMed 780G System Utilizing Insulin Lyumjev®

Primary outcome

Primary Safety Endpoint - Change in HbA1c
Time frame: 3 months
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL)
Time frame: Last 6-7 weeks of 3 month study period
The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.

2 secondary outcomes

Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Time frame: Last 6-7 weeks of 3 month study period
Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL)
Time frame: Last 6-7 weeks of 3 month study period

Results and safety

Results posted to the registry on 15 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects 7-17 Years of Age	101	97
Subjects 18-80 Years of Age	110	101

Primary outcome: Primary Safety Endpoint - Change in HbA1c

Time frame: 3 months. Mean (Standard Deviation). Unit: percentage of HbA1c

Measure	Subjects 7-17 Years of Age n = 99	Subjects 18-80 Years of Age n = 108
Value	-0.1 (0.7)	-0.4 (0.6)

Subjects 7-17 Years of Age: Mean difference from baseline to exit: -0.1 (95% CI -0.2 to 0.1), p = 0.133, t-test, 1 sided
Subjects 18-80 Years of Age: Mean difference from baseline to exit: -0.4 (95% CI -0.6 to -0.3), p <0.001, Wilcoxon (Mann-Whitney)

Population analysed: Intention to Treat Population with available data. Two subjects aged 7-17 and two subject aged 18-80 did not collect A1C at the end of the study period, so 99 subjects aged 7-17 and 108 subjects aged 18-80 were analyzed at end of study period and the change from baseline to end of study period.

Primary outcome: Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL)

Time frame: Last 6-7 weeks of 3 month study period. Mean (Standard Deviation). Unit: percentage of Time in Range (TIR 70-180

Measure	Subjects 7-17 Years of Age n = 98	Subjects 18-80 Years of Age n = 102
Value	68.6 (10.3)	77.6 (9.6)

Subjects 7-17 Years of Age: Mean of Final Value: 68.6 (95% CI 66.6 to 70.7), p <0.001, t-test, 1 sided
Subjects 18-80 Years of Age: Mean of Final Value: 77.6 (95% CI 75.7 to 79.4), p <0.001, t-test, 1 sided

Population analysed: Intention to Treat Population with available data. Three subjects aged 7-17 and eight subject aged 18-80 did not have enough SG points at the last 6 weeks of the study period, so 98 subjects aged 7-17 and 102 subjects aged 18-80 were analyzed at last 6 weeks of study period.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3-month Study Period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects 7-17 Years of Age Study Period	0 of 101 (0%)	50 of 101 (49.5%)	0 of 101
Subjects 18-80 Years of Age Study Period	0 of 110 (0%)	47 of 110 (42.7%)	0 of 110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MiniMed 780G System in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint - Change in HbA1c (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05325294.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.