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

Primary Purpose

Type 1 Diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulin Pump with Continuous Glucose Monitoring
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

7 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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) Exclusion Criteria: 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. 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).

Sites / Locations

  • Medical Investigations
  • Stanford University
  • University of California San Francisco (UCSF) The Madison Clinic for Pediatric Diabetes
  • Sansum Diabetes Research Institute
  • Diablo Clinical Research
  • Barbara Davis Center for Childhood Diabetes
  • Yale School of Medicine
  • University of South Florida (USF) Diabetes Center
  • Atlanta Diabetes Associates
  • Endocrine Research Solutions
  • Rocky Mountain Diabetes and Osteoporosis Center
  • Joslin Diabetes Center
  • Park Nicollet International Diabetes Center
  • Childrens Hospital and Clinics of Minnesota
  • New York University (NYU) Langone Hospital Long Island
  • Northwell Health for Cohen Children's Medical Center of New York
  • University Hospitals Rainbow Babies & Childrens Hospital
  • Children's Hospital of Philadelphia
  • AM Diabetes and Endocrinology Center
  • Texas Diabetes and Endocrinology
  • Rainier Clinical Research Center
  • Seattle Childrens Hospital
  • Multicare Institute for Research and Innovation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MiniMed™ 780G system with DS5

Arm Description

Subjects with type 1 diabetes wearing the MiniMed™ 780G insulin pump in combination with the DS5 CGM.

Outcomes

Primary Outcome Measures

Primary Safety Endpoint for Age 18-80 - Change in HbA1c
Age 18-80: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Primary Safety Endpoint for Age 7-17 - Change in HbA1c
Age 7-17: 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)
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.

Secondary Outcome Measures

Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Age 18-80: The mean % of time in hypoglycemia (< 54 mg/dL) . Non-inferiority test.
Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Age 7-17: The mean % of time in hypoglycemia (< 54 mg/dL). Non-inferiority test.
Secondary Effectiveness Endpoint 2 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).Superiority test.
Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL ).Superiority test.

Full Information

First Posted
January 26, 2023
Last Updated
October 12, 2023
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT05714059
Brief Title
Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM
Official Title
Safety and Effectiveness Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MiniMed™ 780G system with DS5
Arm Type
Experimental
Arm Description
Subjects with type 1 diabetes wearing the MiniMed™ 780G insulin pump in combination with the DS5 CGM.
Intervention Type
Device
Intervention Name(s)
Insulin Pump with Continuous Glucose Monitoring
Intervention Description
MiniMed™ 780G insulin pump in combination with the DS5 CGM
Primary Outcome Measure Information:
Title
Primary Safety Endpoint for Age 18-80 - Change in HbA1c
Description
Age 18-80: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Time Frame
3 months
Title
Primary Safety Endpoint for Age 7-17 - Change in HbA1c
Description
Age 7-17: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Time Frame
3 months
Title
Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
Description
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Time Frame
3 months
Title
Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)
Description
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Description
Age 18-80: The mean % of time in hypoglycemia (< 54 mg/dL) . Non-inferiority test.
Time Frame
3 months
Title
Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Description
Age 7-17: The mean % of time in hypoglycemia (< 54 mg/dL). Non-inferiority test.
Time Frame
3 months
Title
Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
Description
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL).Superiority test.
Time Frame
3 months
Title
Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)
Description
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL ).Superiority test.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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) Exclusion Criteria: 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. 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).
Facility Information:
Facility Name
Medical Investigations
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California San Francisco (UCSF) The Madison Clinic for Pediatric Diabetes
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
University of South Florida (USF) Diabetes Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Endocrine Research Solutions
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Park Nicollet International Diabetes Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Childrens Hospital and Clinics of Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
New York University (NYU) Langone Hospital Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Northwell Health for Cohen Children's Medical Center of New York
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
University Hospitals Rainbow Babies & Childrens Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
AM Diabetes and Endocrinology Center
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Texas Diabetes and Endocrinology
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Seattle Childrens Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Multicare Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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