Type 1 DiabetesSUCCEED2NCT06604871
Safety Evaluation of MiniMed™ 780G System With DS5 CGM in Children
A study testing Insulin Pump with Continuous Glucose Monitoring in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 pediatric subjects (2-6 years of age) in a home setting. Read more about this study
- Who is it for?
- Ages 2 to 6 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
- 56 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Oct 2024to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-6 years at time of screening.
- Has a clinical diagnosis of type 1 diabetes for 3 months or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
- Parent(s)/guardian(s) is/are literate and able to read the language offered in the pump or pump materials.
- Subject or parent(s)/guardian(s) is/are 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.
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- Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 6 units on average.
- 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 collected via fingerstick and sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
- 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 per manufacturers labeling:
- Humalog (insulin lispro injection)
- Authorized generic insulin lispro
- NovoLog (insulin aspart injection)
- Authorized generic insulin aspart
- Admelog (insulin lispro injection) - for subjects aged 3 years and older only
- Has 1 month or more of CGM experience at time of screening.
- If subject has been diagnosed with hyperthyroidism or hypothyroidism, he/she must have a TSH within 3 months prior to screening or at time of screening.
Who cannot join
- Has a history of 1 or more episodes of severe hypoglycemia during the 3 months prior to screening.
- Has been hospitalized or has visited the emergency room (ER) in the 3 months prior to screening resulting with a primary diagnosis of uncontrolled diabetes.
- Has had DKA in the last 3 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).
- Has diagnosis of adrenal insufficiency.
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- 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.
- Is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
- Parent(s)/guardian(s) 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.
- History of chronic renal disease or currently on hemodialysis
- Has hemophilia or any other bleeding disorder.
- Has celiac disease that is not adequately treated as determined by the investigator.
- Has a cardiovascular condition which the investigator determines must exclude the subject.
- Has hyperthyroidism or hypothyroidism that is not adequately treated as determined by the investigator.
- Is an immediate family member of a Medtronic Diabetes employee.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Texas Childrens Hospital
Houston, Texas, 77030
Nemours Childrens Specialty Care
Jacksonville, Florida, 32207
Yale School of Medicine
New Haven, Connecticut, 06511
Stanford University
Palo Alto, California, 94304
UCSF The Madison Clinic for Pediatric Diabetes
San Francisco, California, 94158
USF Diabetes and Endocrinology Center
Tampa, Florida, 33612
About this study
Official title: Safety Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM in Children 2-6 Years of Age
The purpose of this study is to evaluate the safety of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 pediatric subjects (2-6 years of age) in a home setting.
Read the detailed description
This study is a multi-center, single arm study in insulin-requiring pediatric subjects with type 1 diabetes on the MiniMed 780G system using DS5. The run-in period and study period, together, will be approximately 130 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 group | Role | What they receive |
|---|---|---|
| MiniMed™ 780G system with DS5 | Experimental | Subjects 2-6 years old 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 Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL)
Percent of Time in Range (TIR 70-180 mg/dL). Descriptive only.
Measured: Last 6-7 weeks of study period.
Primary Safety Endpoints - Incidence of Adverse Events
The safety data associated with diabetes management will be summarized:
- Serious Adverse Events (SAE)
- Serious Adverse Device Effects (SADE)
- Unanticipated Adverse Device Effects
- Incidence of Severe Hypoglycemia
- Incidence of Severe Hyperglycemia
- Incidence of DKA
The details of all AEs will also be presented under Reported Adverse Events in ClinicalTrials.gov.
Measured: Through study completion, approximately 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start29 Oct 2024
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604871
- Sponsor's protocol ID
- CIP344
- Acronym
- SUCCEED2
- Status last verified
- Oct 2025
- First submitted
- 17 Sep 2024
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM in Children 2-6 Years of Age
- ClinicalTrials.gov ID
- NCT06604871
- Acronym / sponsor ID
- SUCCEED2 / CIP344
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 pediatric subjects (2-6 years of age) in a home setting.
Detailed description
This study is a multi-center, single arm study in insulin-requiring pediatric subjects with type 1 diabetes on the MiniMed 780G system using DS5. The run-in period and study period, together, will be approximately 130 days long.
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 2-6 years old with type 1 diabetes wearing the MiniMed™ 780G insulin pump in combination with the DS5 CGM. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Age 2-6 years at time of screening.
- Has a clinical diagnosis of type 1 diabetes for 3 months or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
- Parent(s)/guardian(s) is/are literate and able to read the language offered in the pump or pump materials.
- Subject or parent(s)/guardian(s) is/are willing to provide informed consent for participation.
- Is willing to perform fingerstick blood glucose measurements as needed.
Key exclusion criteria (21 listed)
- Has a history of 1 or more episodes of severe hypoglycemia during the 3 months prior to screening.
- Has been hospitalized or has visited the emergency room (ER) in the 3 months prior to screening resulting with a primary diagnosis of uncontrolled diabetes.
- Has had DKA in the last 3 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 Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL)
Time frame: Last 6-7 weeks of study period.
Percent of Time in Range (TIR 70-180 mg/dL). Descriptive only.
Primary Safety Endpoints - Incidence of Adverse Events
Time frame: Through study completion, approximately 18 months.
The safety data associated with diabetes management will be summarized: * Serious Adverse Events (SAE) * Serious Adverse Device Effects (SADE) * Unanticipated Adverse Device Effects * Incidence of Severe Hypoglycemia * Incidence of Severe Hyperglycemia * Incidence of DKA The details of all AEs will also be presented under Reported Adverse Events in ClinicalTrials.gov.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- 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.
8 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 8 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 21 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 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) (time frame: Last 6-7 weeks of study period.). 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?
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 8 Oct 2025.