Type 1 Diabetes
Conditions
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.
Interventions
MiniMed™ 780G insulin pump in combination with the DS5 CGM
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 80 Years
Healthy volunteers
No
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 the language offered in the pump or pump materials. 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. 9. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit. 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 insulin preparations as required by the study: 1. Humalog (insulin lispro injection) 2. NovoLog (insulin aspart injection) 3. Admelog (insulin lispro injection)
Exclusion criteria
1. 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 2. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes. 3. Has had DKA in the last 6 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. Is female of child-bearing potential and result of pregnancy test is positive at screening. 7. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator. 8. Is female and plans to become pregnant during the course of the study. 9. Is being treated for hyperthyroidism at time of screening. 10. Has diagnosis of adrenal insufficiency. 11. 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. 12. Is using hydroxyurea at time of screening or plans to use it during the study. 13. 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. 14. Has used a MiniMed 780G pump prior to screening. 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. 34. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint - Change in HbA1c | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL) | Last 6-7 weeks of 3 month study period | The mean % of time in hypoglycemia (\< 54 mg/dL) . Non-inferiority test. |
| Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL) | Last 6-7 weeks of 3 month study period | The mean % of time in range (TIR 70-180 mg/dL ).Superiority test. |
Countries
United States
Participant flow
Pre-assignment details
250 subjects (125 with age 7-17 and 125 with age 18-80) enrolled at the beginning, with 20 (7 with age7-17 and 13 with age 18-80) screen failure, 8 subjects (6 with age 7-17 and 2 with age 18-80) early withdrawn, 222 subjects (112 with age 7-17 and 110 with age 18-80) were left as the Intention to Treat Population and started the study.
Participants by arm
| Arm | Count |
|---|---|
| Subjects 7-17 Years of Age Subjects 7-17 years of age wearing MiniMed™ 780G System With DS5 CGM | 112 |
| Subjects 18-80 Years of Age Subjects 18-80 years of age wearing MiniMed™ 780G System With DS5 CGM | 110 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | TECHNICAL PROBLEMS | 0 | 1 |
| Overall Study | WITHDRAWAL BY PARENT/GUARDIAN | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Subjects 7-17 Years of Age | Subjects 18-80 Years of Age | Total |
|---|---|---|---|
| Age, Continuous | 13.3 years STANDARD_DEVIATION 3 | 46.7 years STANDARD_DEVIATION 15.8 | 29.8 years STANDARD_DEVIATION 20.2 |
| BMI | 21.9 kg/m^2 STANDARD_DEVIATION 4.8 | 28.8 kg/m^2 STANDARD_DEVIATION 5.9 | 25.3 kg/m^2 STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 5 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants | 105 Participants | 206 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 95 Participants | 104 Participants | 199 Participants |
| Sex: Female, Male Female | 48 Participants | 56 Participants | 104 Participants |
| Sex: Female, Male Male | 64 Participants | 54 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 110 |
| other Total, other adverse events | 46 / 112 | 35 / 110 |
| serious Total, serious adverse events | 0 / 112 | 3 / 110 |
Outcome results
Primary
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.
Time frame: Last 6-7 weeks of 3 month study period
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects 7-17 Years of Age | Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL) | 71.4 percentage of Time in Range (TIR 70-180) | Standard Deviation 9.9 |
| Subjects 18-80 Years of Age | Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL) | 80.2 percentage of Time in Range (TIR 70-180) | Standard Deviation 8.1 |
p-value: <0.00195% CI: [69.5, 73.3]Wilcoxon (Mann-Whitney)
p-value: <0.00195% CI: [78.7, 81.8]t-test, 1 sided
Primary
Primary Safety Endpoint - Change in HbA1c
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Time frame: 3 months
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects 7-17 Years of Age | Primary Safety Endpoint - Change in HbA1c | -0.4 percentage of HbA1c | Standard Deviation 0.8 |
| Subjects 18-80 Years of Age | Primary Safety Endpoint - Change in HbA1c | -0.7 percentage of HbA1c | Standard Deviation 0.7 |
p-value: <0.00195% CI: [-0.6, -0.3]Wilcoxon (Mann-Whitney)
p-value: <0.00195% CI: [-0.8, -0.6]t-test, 1 sided
Secondary
Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL)
The mean % of time in hypoglycemia (\< 54 mg/dL) . Non-inferiority test.
Time frame: Last 6-7 weeks of 3 month study period
Population: Intention to Treat Population and Time in hypoglycemia metrics were available from last 6-7 weeks of 3 month study period. Time in hypoglycemia 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects 7-17 Years of Age | Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL) | 0.4 percentage of Time in Hypoglycemia(< 54) | Standard Deviation 0.3 |
| Subjects 18-80 Years of Age | Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL) | 0.2 percentage of Time in Hypoglycemia(< 54) | Standard Deviation 0.4 |
p-value: <0.00195% CI: [0.3, 0.4]Wilcoxon (Mann-Whitney)
p-value: <0.00195% CI: [0.1, 0.3]Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Last 6-7 weeks of 3 month study period
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects 7-17 Years of Age | Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL) | 71.4 percentage of Time in Range (70-180) | Standard Deviation 9.9 |
| Subjects 18-80 Years of Age | Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL) | 80.2 percentage of Time in Range (70-180) | Standard Deviation 8.1 |
p-value: <0.00195% CI: [69.5, 73.3]Wilcoxon (Mann-Whitney)
p-value: <0.00195% CI: [78.7, 81.8]t-test, 1 sided