COMPLETED

Safety Evaluation of MiniMed™ 780G System With DS5 CGM in Children

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM in Children 2-6 Years of Age

Quick Facts

Study Start:2024-10-29

Study Completion:2025-09-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06604871

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 6 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Age 2-6 years at time of screening. 2. 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. 3. Parent(s)/guardian(s) is/are literate and able to read the language offered in the pump or pump materials. 4. Subject or parent(s)/guardian(s) is/are willing to provide informed consent for participation. 5. Is willing to perform fingerstick blood glucose measurements as needed. 6. Is willing to wear the system continuously throughout the study. 7. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 6 units on average. 8. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit. 9. 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. 10. 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: 1. Humalog (insulin lispro injection) 2. Authorized generic insulin lispro 3. NovoLog (insulin aspart injection) 4. Authorized generic insulin aspart 5. Admelog (insulin lispro injection) - for subjects aged 3 years and older only 11. Has 1 month or more of CGM experience at time of screening. 12. 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.	1. Has a history of 1 or more episodes of severe hypoglycemia during the 3 months prior to screening. 2. 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. 3. Has had DKA in the last 3 months prior to screening visit. 4. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual. 5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection). 6. Has diagnosis of adrenal insufficiency. 7. 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. 8. Is using hydroxyurea at time of screening or plans to use it during the study. 9. 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. 10. 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. 11. 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. 12. Has elective surgery planned that requires general anesthesia during the course of the study. 13. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening. 14. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation. 15. Is diagnosed with current eating disorder such as anorexia or bulimia. 16. History of chronic renal disease or currently on hemodialysis 17. Has hemophilia or any other bleeding disorder. 18. Has celiac disease that is not adequately treated as determined by the investigator. 19. Has a cardiovascular condition which the investigator determines must exclude the subject. 20. Has hyperthyroidism or hypothyroidism that is not adequately treated as determined by the investigator. 21. Is an immediate family member of a Medtronic Diabetes employee.

Inclusion Criteria

Exclusion Criteria

1. Age 2-6 years at time of screening.
2. 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.
3. Parent(s)/guardian(s) is/are literate and able to read the language offered in the pump or pump materials.
4. Subject or parent(s)/guardian(s) is/are willing to provide informed consent for participation.
5. Is willing to perform fingerstick blood glucose measurements as needed.
6. Is willing to wear the system continuously throughout the study.
7. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 6 units on average.
8. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
9. 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.
10. 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:
1. Humalog (insulin lispro injection)
2. Authorized generic insulin lispro
3. NovoLog (insulin aspart injection)
4. Authorized generic insulin aspart
5. Admelog (insulin lispro injection) - for subjects aged 3 years and older only
11. Has 1 month or more of CGM experience at time of screening.
12. 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.

1. Has a history of 1 or more episodes of severe hypoglycemia during the 3 months prior to screening.
2. 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.
3. Has had DKA in the last 3 months prior to screening visit.
4. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
6. Has diagnosis of adrenal insufficiency.
7. 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.
8. Is using hydroxyurea at time of screening or plans to use it during the study.
9. 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.
10. 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.
11. 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.
12. Has elective surgery planned that requires general anesthesia during the course of the study.
13. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
14. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
15. Is diagnosed with current eating disorder such as anorexia or bulimia.
16. History of chronic renal disease or currently on hemodialysis
17. Has hemophilia or any other bleeding disorder.
18. Has celiac disease that is not adequately treated as determined by the investigator.
19. Has a cardiovascular condition which the investigator determines must exclude the subject.
20. Has hyperthyroidism or hypothyroidism that is not adequately treated as determined by the investigator.
21. Is an immediate family member of a Medtronic Diabetes employee.

Contacts and Locations

Study Locations (Sites)

Stanford University

Palo Alto, California, 94304

United States

UCSF The Madison Clinic for Pediatric Diabetes

San Francisco, California, 94158

United States

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045

United States

Yale School of Medicine

New Haven, Connecticut, 06511

United States

Nemours Childrens Specialty Care

Jacksonville, Florida, 32207

United States

USF Diabetes and Endocrinology Center

Tampa, Florida, 33612

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Texas Childrens Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Medtronic Diabetes

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-29

Study Completion Date2025-09-26

Study Record Updates

Study Start Date2024-10-29

Study Completion Date2025-09-26

Terms related to this study

Additional Relevant MeSH Terms

Type 1 Diabetes