Type 1 DiabetesNCT05714059

Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM

A study testing Insulin Pump with Continuous Glucose Monitoring in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 23 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

The purpose of this study is to confirm the safety and effectiveness of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 diabetes adult and pediatric subjects in a home setting. 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?: Insulin Pump with Continuous Glucose Monitoring
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 23 sitesUnited States
Study dates: 28 Feb 2023to 29 Dec 2023
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.

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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.
Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
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 prior to screening (with or without CGM experience).
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 by the study:
Humalog (insulin lispro injection)
NovoLog (insulin aspart injection)
Admelog (insulin lispro injection)

Who cannot join

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.
Has had DKA in the last 6 months prior to screening visit.

Show all 45Show fewer

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 glucocorticoids 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.
Has used a MiniMed 780G pump prior to screening.
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.
Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, 38133
Joslin Diabetes Center
Boston, Massachusetts, 02215
University Hospitals Rainbow Babies & Childrens Hospital
Cleveland, Ohio, 44106
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404
Medical Investigations
Little Rock, Arkansas, 72211
New York University (NYU) Langone Hospital Long Island
Mineola, New York, 11501
Yale School of Medicine
New Haven, Connecticut, 06511
Northwell Health for Cohen Children's Medical Center of New York
New Hyde Park, New York, 11042
Stanford University
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Rainier Clinical Research Center
Renton, Washington, 98057
Endocrine Research Solutions
Roswell, Georgia, 30076
Texas Diabetes and Endocrinology
Round Rock, Texas, 78681
Park Nicollet International Diabetes Center
Saint Louis Park, Minnesota, 55416
Childrens Hospital and Clinics of Minnesota
Saint Paul, Minnesota, 55102
University of California San Francisco (UCSF) The Madison Clinic for Pediatric Diabetes
San Francisco, California, 94158
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
Seattle Childrens Hospital
Seattle, Washington, 98105
Multicare Institute for Research and Innovation
Tacoma, Washington, 98405
University of South Florida (USF) Diabetes Center
Tampa, Florida, 33612
Diablo Clinical Research
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: Safety and Effectiveness Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM

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 DS5 as well as Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long.

Conditions: Type 1 Diabetes
Being tested: Insulin Pump with Continuous Glucose Monitoring
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.

Insulin Pump with Continuous Glucose MonitoringDevice
MiniMed™ 780G insulin pump in combination with the DS5 CGM

Study groups in NCT05714059
Study group	Role	What they receive
MiniMed™ 780G system with DS5	Experimental	Subjects with type 1 diabetes wearing the MiniMed™ 780G insulin pump in combination with the DS5 CGM. Receives: Device: Insulin Pump with Continuous Glucose Monitoring

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 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
Age 18-80: 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.

28 Feb 202329 Dec 2023

First posted6 Feb 2023
Study start28 Feb 2023
Primary completion29 Dec 2023
Study completion29 Dec 2023

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: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05714059
Sponsor's protocol ID: CIP337
Status last verified: Jan 2025
First submitted: 26 Jan 2023
Last updated: 17 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Effectiveness Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM
ClinicalTrials.gov ID: NCT05714059
Acronym / sponsor ID: CIP337
Conditions: Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: 28 Feb 2023 (actual)
Primary completion: 29 Dec 2023 (actual)
Study completion: 29 Dec 2023 (actual)
First posted: 6 Feb 2023 (actual)
Results: Posted 17 Feb 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 with DS5	Experimental	Device: Insulin Pump with Continuous Glucose MonitoringSubjects with type 1 diabetes wearing the MiniMed™ 780G insulin pump in combination with the DS5 CGM.

Who may qualify

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

Key inclusion criteria (18 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 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.
Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

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
Insulin Pump with Continuous Glucose MonitoringMiniMed™ 780G insulin pump in combination with the DS5 CGM	Device	MiniMed™ 780G system with DS5

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 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
Time frame: Last 6-7 weeks of 3 month study period
Age 18-80: 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 17 Feb 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	112	107
Subjects 18-80 Years of Age	110	105

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 = 111	Subjects 18-80 Years of Age n = 106
Value	-0.4 (0.8)	-0.7 (0.7)

Subjects 7-17 Years of Age: Mean difference from baseline to exit: -0.4 (95% CI -0.6 to -0.3), p <0.001, Wilcoxon (Mann-Whitney)
Subjects 18-80 Years of Age: Mean difference from baseline to exit: -0.7 (95% CI -0.8 to -0.6), p <0.001, t-test, 1 sided

Population analysed: Intention to Treat Population" to "Intention to Treat Population and HbA1c at exit were collected. HbA1c at exit were collected from 217 subjects in intention to treat population (111 subjects with age 7-17 and 106 subjects with age 18-80)

Primary outcome: Primary Effectiveness Endpoint for Age 18-80 - 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 = 109	Subjects 18-80 Years of Age n = 107
Value	71.4 (9.9)	80.2 (8.1)

Subjects 7-17 Years of Age: Mean value (Final Values): 71.4 (95% CI 69.5 to 73.3), p <0.001, Wilcoxon (Mann-Whitney)
Subjects 18-80 Years of Age: Mean value (Final Values): 80.2 (95% CI 78.7 to 81.8), p <0.001, t-test, 1 sided

Population analysed: Intention to Treat Population and Time in range metric were available from last 6-7 weeks of 3 month study period. Time in range metrics from last 6-7 weeks of 3 month study period were available from 216 subjects in intention to treat population (109 subjects with age 7-17 and 107 subjects with age 18-80)

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	0 of 112 (0%)	46 of 112 (41.1%)	0 of 112
Subjects 18-80 Years of Age	3 of 110 (2.7%)	35 of 110 (31.8%)	0 of 110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Insulin Pump with Continuous Glucose Monitoring in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 23 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 18 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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 17 Feb 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 NCT05714059.

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 17 Feb 2025.