Diabetes Mellitus, Type 1
Conditions
Brief summary
This is a pilot outpatient study conducted at Stanford to obtain preliminary data on how Fiasp® works in a closed-loop system and to determine if any changes need to be made to the 670G pump to optimize the use of Fiasp®.
Detailed description
This will be a randomized cross-over blinded study and to see how the 670G pump responds to the introduction of Fiasp® insulin. Subjects enrolled in the study will have a 2 week period of optimization with weekly assessments of their Carelink download before entering the blinded phase of the study. They will use their usual home insulin during the optimization phase. They will then be started on their first blinded insulin (aspart or Fiasp®) which they will use for 2 weeks, before they cross-over to the other insulin.
Interventions
Sponsors
Medtronic
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded
Intervention model description
Subjects will be randomly assigned to start with either Fiasp insulin or Novolog insulin. After 2 weeks, they will start the previously unassigned insulin and continue using it for another 2 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of type 1 diabetes and using 670G pump for at least 1 month, and willing to have the 670G pump downloaded into a Carelink Clinical research database. 2. The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed. 3. Age ≥18 years 4. Using Novolog or Fiasp® insulin at time of enrollment 5. Willing to use Fiasp® insulin 6. Total daily insulin dose is at least 0.3 units/kg/day 7. Usual carbohydrate intake is at least 60 grams a day, and willing to have at least 25 grams of carbohydrates for breakfast 8. For females, not currently known to be pregnant 9. An understanding of and willingness to follow the protocol and sign the informed consent 10. Willing to have photographs taken of their infusion sites 11. Willing to download their 670G pump every 1-2 weeks to a research Carelink account 12. Willingness to answer a brief online questionnaire every 2 weeks 13. Must be able to understand spoken or written English 14. For subjects participating in Part 2 of this study they will need to be using Fiasp® as part of their usual care 15. Hemoglobin A1c between 6 and 10% at the time of enrollment
Exclusion criteria
1. Pregnant or lactating females 2. No hypoglycemic seizure or loss of consciousness in the past 6 months 3. Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure 4. No known cardiovascular events in the last 6 months 5. No active proliferative diabetic retinopathy 6. Known tape allergies 7. Current treatment for a seizure disorder 8. Cystic fibrosis 9. Active infection 10. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol 11. Inpatient psychiatric treatment in the past 6 months 12. Presence of a known adrenal disorder 13. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, with lack of stability on the medication for the past 2 months prior to enrollment in the study 14. Abuse of alcohol 15. Dialysis or renal failure 16. Known eGFR \<60% Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl | 7 days (during 2nd half of 2-week intervention period) | Measured as percentage of time in range (days). |
| Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl | 7 days (during 2nd half of 2-week intervention period) | Percentage of time in range (days) as a measure of hypoglycemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Sensor Glucose in mg/dl | 7 days (during 2nd half of 2-week intervention period) | Mean sensor data over the second week of using a randomized, blinded insulin. |
Countries
United States
Participant flow
Pre-assignment details
27 participants signed informed consent. 3 participants failed screening and did not enter the run-in period (a 2-week period for pump-setting adjustments and monitoring).
Participants by arm
| Arm | Count |
|---|---|
| Fiasp Then Novolog Following a 2-week run-in period, participants use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks. | 10 |
| Novolog Then Fiasp Following a 2-week run-in period, participants use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Run-in Period (2 Weeks) | Lost to Follow-up | 2 | 0 | 0 |
| Run-in Period (2 Weeks) | Need for steroid injection | 1 | 0 | 0 |
| Treatment Period 1 (2 Weeks) | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Fiasp Then Novolog | Novolog Then Fiasp | Total |
|---|---|---|---|
| Age, Continuous | 37.0 years STANDARD_DEVIATION 15.2 | 44.1 years STANDARD_DEVIATION 20.4 | 40.4 years STANDARD_DEVIATION 17.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1C | 7.1 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.9 | 7.1 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.5 | 7.1 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 9 Participants | 18 Participants |
| Region of Enrollment United States | 10 participants | 9 participants | 19 participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 28 | 0 / 19 | 1 / 19 |
| serious Total, serious adverse events | 0 / 28 | 0 / 19 | 1 / 19 |
Outcome results
Primary
Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl
Percentage of time in range (days) as a measure of hypoglycemia.
Time frame: 7 days (during 2nd half of 2-week intervention period)
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fiasp Insulin | Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl | 2.3 percentage of time | Standard Deviation 2 |
| Novolog Insulin | Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl | 3.1 percentage of time | Standard Deviation 2.1 |
p-value: 0.17t-test, 2 sided
Primary
Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl
Measured as percentage of time in range (days).
Time frame: 7 days (during 2nd half of 2-week intervention period)
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fiasp Insulin | Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl | 78.4 percentage of time | Standard Deviation 9.3 |
| Novolog Insulin | Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl | 75.3 percentage of time | Standard Deviation 9.5 |
p-value: 0.051t-test, 2 sided
Secondary
Mean Sensor Glucose in mg/dl
Mean sensor data over the second week of using a randomized, blinded insulin.
Time frame: 7 days (during 2nd half of 2-week intervention period)
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fiasp Insulin | Mean Sensor Glucose in mg/dl | 146 mg/dL | Standard Deviation 12 |
| Novolog Insulin | Mean Sensor Glucose in mg/dl | 147 mg/dL | Standard Deviation 12 |
p-value: 0.74t-test, 2 sided