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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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®.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiasp then Novolog | Experimental | Following a 2-week run-in period for pump-setting adjustments and monitoring, participants 1 will use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks. Both the subject and the investigator will be blinded to which group the subject is assigned. |
|
| Novolog then Fiasp | Experimental | Following a 2-week run-in period for pump-setting adjustments and monitoring, participants 1 will use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks. Both the subject and the investigator will be blinded to which group the subject is assigned. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiasp | Drug | Fiasp insulin will be used for 2 weeks with the 670G hybrid closed-loop system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl | Measured as percentage of time in range (days). | 7 days (during 2nd half of 2-week intervention period) |
| Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl | Percentage of time in range (days) as a measure of hypoglycemia. | 7 days (during 2nd half of 2-week intervention period) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sensor Glucose in mg/dl | Mean sensor data over the second week of using a randomized, blinded insulin. | 7 days (during 2nd half of 2-week intervention period) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Buckingham, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Stanford |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28918652 | Background | Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18. | |
| 28055230 | Background | Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants (run-in Period) | Participants entered a 2-week run-in period prior to randomization. |
| FG001 | Fiasp Then Novolog | Following randomization after a 2-week run-in period, participants use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks. |
| FG002 | Novolog Then Fiasp | Following randomization after a 2-week run-in period, participants use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-in Period (2 Weeks) |
|
| |||||||||||||||||||||
| Treatment Period 1 (2 Weeks) |
| ||||||||||||||||||||||
| Treatment Period 2 (2 Weeks) |
|
Participants who completed the protocol are included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fiasp Then Novolog | Following a 2-week run-in period, participants use Fiasp insulin for 2 weeks, followed by Novolog insulin for 2 weeks. |
| BG001 | Novolog Then Fiasp | Following a 2-week run-in period, participants use Novolog insulin for 2 weeks, followed by Fiasp insulin for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl | Measured as percentage of time in range (days). | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | percentage of time | 7 days (during 2nd half of 2-week intervention period) |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in Period | Participants with events occurring prior to randomization. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion set failure | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation/Inflammation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bruce Buckingham | Stanford | 6508040476 | buckingham@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2018 | May 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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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.
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Double-blinded
| Novolog | Drug | Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system |
|
|
| Palo Alto |
| California |
| 94305 |
| United States |
| 32520594 | Background | Hsu L, Buckingham B, Basina M, Ekhlaspour L, von Eyben R, Wang J, Lal RA. Fast-Acting Insulin Aspart Use with the MiniMedTM 670G System. Diabetes Technol Ther. 2021 Jan;23(1):1-7. doi: 10.1089/dia.2020.0083. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Hemoglobin A1C | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl | Percentage of time in range (days) as a measure of hypoglycemia. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | percentage of time | 7 days (during 2nd half of 2-week intervention period) |
|
|
|
|
| Secondary | Mean Sensor Glucose in mg/dl | Mean sensor data over the second week of using a randomized, blinded insulin. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | mg/dL | 7 days (during 2nd half of 2-week intervention period) |
|
|
|
|
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Fiasp Insulin | Participants with events occurring during Fiasp insulin treatment. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Novolog Insulin | Participants with events occurring during Novolog insulin treatment. | 0 | 19 | 1 | 19 | 1 | 19 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |