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Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MiniMed 780G System
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:

  1. Age 7 - 80 years at time of screening.
  2. Has a clinical diagnosis of type 1 diabetes:

    1. 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.
    2. 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.
  3. Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
  4. Subject or parent/caregiver is literate and able to read one of the languages offered in the pump.
  5. Subject and/or legally authorized representative is willing to provide informed consent for participation.
  6. Is willing to perform fingerstick blood glucose measurements as needed.
  7. Is willing to wear the system continuously throughout the study.
  8. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units and maximum total daily dose of 250 units or less.
  9. 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.

  10. 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.
  11. Uses pump therapy for greater than 6 months prior to screening (with or without CGM experience)
  12. 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.
  13. Is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations as required during the run-in period:

    1. Humalog (insulin lispro injection)
    2. NovoLog/NovoRapid (insulin aspart injection)
  14. Is willing to take Fiasp insulin during the study period (supplied via Sponsor).

EXCLUSION CRITERIA:

  1. Has hypersensitivity to insulin aspart or one of the excipients in Fiasp.
  2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:

    1. Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)
    2. Coma
    3. Seizures
  3. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
  4. Has had DKA in the last 6 months prior to screening visit.
  5. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
  6. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
  7. Is female of child-bearing potential and result of pregnancy test is positive at screening.
  8. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
  9. Is female and plans to become pregnant during the course of the study.
  10. Is being treated for hyperthyroidism at time of screening.
  11. Has diagnosis of adrenal insufficiency.
  12. 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.
  13. Is using hydroxyurea at time of screening or plans to use it during the study.
  14. 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.
  15. Is currently abusing illicit drugs.
  16. Is currently abusing marijuana.
  17. Is currently abusing prescription drugs.
  18. Is currently abusing alcohol.
  19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
  20. 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.
  21. Has elective surgery planned that requires general anesthesia during the course of the study.
  22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
  23. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
  24. Is diagnosed with current eating disorder such as anorexia or bulimia.
  25. Has been diagnosed with chronic kidney disease that results in chronic anemia.
  26. Has a hematocrit that is below the normal reference range of lab used.
  27. Is on dialysis.
  28. Has serum creatinine of >2 mg/dL.
  29. Has celiac disease that is not adequately treated as determined by the investigator.
  30. 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.
  31. Has had history of cardiovascular event 1 year or more from the time of screening without

    1. a normal EKG and stress test within 6 months prior to screening or during screening or
    2. clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test.
  32. 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
  33. Is a member of the research staff involved with the study.

Sites / Locations

  • Medical Investigations, Inc.Recruiting
  • Valley Research
  • Center of Excellence in Diabetes & EndocrinologyRecruiting
  • Rady's Children's HospitalRecruiting
  • Barbara Davis Center for Diabetes
  • University of South FloridaRecruiting
  • Atlanta Diabetes Associates
  • Endocrine Research Solutions
  • Rocky Mountain Clinical Research
  • Barry J Reiner MD, LLCRecruiting
  • The Docs, LLCRecruiting
  • Physicians East
  • Diabetes and Glandular Disease Clinic, P.A.Recruiting
  • Rainier Clinical Research Center
  • MultiCare Institute for Research & InnovationRecruiting
  • Alberta Children's Hospital Research InstituteRecruiting
  • McMaster Children's Hospital
  • LMC Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MiniMed 780G System Utilizing Insulin Fiasp

Arm Description

Subjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.

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 [3.9 -10.0 mmol/L])
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]). Non-inferiority test.
Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]). Non-inferiority test.

Secondary Outcome Measures

Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
Age 18-80: The mean % of time in hypoglycemia (< 54 mg/dL [3.0 mmol/L]). Non-inferiority test.
Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
Age 7-17: The mean % of time in hypoglycemia (< 54 mg/dL [3.0 mmol/L]). Non-inferiority test.
Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]).Superiority test.
Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]).Superiority test.

Full Information

First Posted
January 24, 2022
Last Updated
August 1, 2023
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT05224258
Brief Title
Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®
Official Title
Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® (Insulin Aspart Injection)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (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
This global study (US, Canada, and Australia) will evaluate the safety and effectiveness of the MiniMed 780G system in type 1 adult and pediatric subjects utilizing Fiasp (insulin aspart injection) in a home setting.
Detailed Description
This global 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 Fiasp insulin as well as 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, Canada, and Australia in order to have 200 subjects enter the study period. Up to 125 subjects will be enrolled in the pediatric age group (7-17 years of age), up to 125 in the adult age group (18 years or older)

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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MiniMed 780G System Utilizing Insulin Fiasp
Arm Type
Experimental
Arm Description
Subjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
Intervention Type
Device
Intervention Name(s)
MiniMed 780G System
Intervention Description
780G System used with Insulin Fiasp® (Insulin Aspart Injection)
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 [3.9 -10.0 mmol/L])
Description
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]). 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 [3.9 -10.0 mmol/L])
Description
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]). 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 [3.0 mmol/L])
Description
Age 18-80: The mean % of time in hypoglycemia (< 54 mg/dL [3.0 mmol/L]). Non-inferiority test.
Time Frame
3 months
Title
Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
Description
Age 7-17: The mean % of time in hypoglycemia (< 54 mg/dL [3.0 mmol/L]). 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 [3.9 -10.0 mmol/L])
Description
Age 18-80: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]).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 [3.9 -10.0 mmol/L])
Description
Age 7-17: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]).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 one of the languages offered in the pump. 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 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 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 either of the 2 insulin preparations as required during the run-in period: Humalog (insulin lispro injection) NovoLog/NovoRapid (insulin aspart injection) Is willing to take Fiasp insulin during the study period (supplied via Sponsor). EXCLUSION CRITERIA: Has hypersensitivity to insulin aspart or one of the excipients in Fiasp. 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Troub
Phone
(818) 576-3142
Email
thomas.troub@medtronic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Reyes
Phone
(818) 576-5323
Email
denise.m.reyes@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Liljenquist, MD
Organizational Affiliation
Rocky Mountain Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Warren, MD
Organizational Affiliation
Physicians East
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Reed, MD
Organizational Affiliation
Endocrine Research Solutions
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald Brazg, MD
Organizational Affiliation
Rainier Clinical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dorothy Shulman, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Bode, MD
Organizational Affiliation
Atlanta Diabetes Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Halis Akturk, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Norwood, MD
Organizational Affiliation
Valley Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carla Demeterco-Berggren, MD
Organizational Affiliation
Rady's Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Abitbol, MD
Organizational Affiliation
LMC Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniele Pacaud, MD
Organizational Affiliation
Alberta Children's Hospital Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Thrasher, MD
Organizational Affiliation
Medical Investigations, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bhuvana Sunil, MD
Organizational Affiliation
MultiCare Institute for Research & Innovation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Kipnes, MD
Organizational Affiliation
Diabetes and Glandular Disease Clinic, P.A.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asheesh Dewan, MD
Organizational Affiliation
The Docs LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barry Reiner, MD
Organizational Affiliation
Barry J Reiner MD LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen McAssey, MD
Organizational Affiliation
McMaster Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gnanagurudasan Prakasam, MD
Organizational Affiliation
Center of Excellence in Diabetes & Endocrinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Investigations, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lesa Thrasher
Email
lesathrasher@yahoo.com
First Name & Middle Initial & Last Name & Degree
James Thrasher, MD
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Center of Excellence in Diabetes & Endocrinology
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Marlen
Email
capitolcts@gmail.com
First Name & Middle Initial & Last Name & Degree
Gnanagurudasan Prakasam, MD
Facility Name
Rady's Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marla Hashiguchi
Phone
858-966-8940
Email
mhashiguchi@rchsd.org
First Name & Middle Initial & Last Name & Degree
Carla Demeterco-Berggren, MD
Facility Name
Barbara Davis Center for Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Rodriguez
Phone
813-974-5499
Email
janetrodriguez@usf.edu
First Name & Middle Initial & Last Name & Degree
Dorothy Shulman, MD
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Endocrine Research Solutions
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Barry J Reiner MD, LLC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Bromberger
Email
reinerstudy.lee@gmail.com
First Name & Middle Initial & Last Name & Degree
Barry Reiner, MD
Facility Name
The Docs, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Torres
Email
torres@thedocs.md
First Name & Middle Initial & Last Name & Degree
Asheesh Dewan, MD
Facility Name
Physicians East
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Diabetes and Glandular Disease Clinic, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terri Ryan
Email
terri.ryan@dgdclinic.com
First Name & Middle Initial & Last Name & Degree
Mark Kipnes, MD
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Schaefer
Email
Becky.Schaefer@multicare.org
First Name & Middle Initial & Last Name & Degree
Bhuvana Sunil, MD
Facility Name
Alberta Children's Hospital Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Virtanen
Email
heidi.virtanen@ahs.ca
First Name & Middle Initial & Last Name & Degree
Daniele Pacaud, MD
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1H4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret McGregor
Email
mcgregorm@HHSC.CA
First Name & Middle Initial & Last Name & Degree
Karen McAssey, MD
Facility Name
LMC Clinical Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®

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