Back to resultsEvaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fiasp
Novolog
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- 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.
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
- Age ≥18 years
- Using Novolog or Fiasp® insulin at time of enrollment
- Willing to use Fiasp® insulin
- Total daily insulin dose is at least 0.3 units/kg/day
- Usual carbohydrate intake is at least 60 grams a day, and willing to have at least 25 grams of carbohydrates for breakfast
- For females, not currently known to be pregnant
- An understanding of and willingness to follow the protocol and sign the informed consent
- Willing to have photographs taken of their infusion sites
- Willing to download their 670G pump every 1-2 weeks to a research Carelink account
- Willingness to answer a brief online questionnaire every 2 weeks
- Must be able to understand spoken or written English
- For subjects participating in Part 2 of this study they will need to be using Fiasp® as part of their usual care
- Hemoglobin A1c between 6 and 10% at the time of enrollment
Exclusion Criteria:
- Pregnant or lactating females
- No hypoglycemic seizure or loss of consciousness in the past 6 months
- Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
- No known cardiovascular events in the last 6 months
- No active proliferative diabetic retinopathy
- Known tape allergies
- Current treatment for a seizure disorder
- Cystic fibrosis
- Active infection
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- Inpatient psychiatric treatment in the past 6 months
- Presence of a known adrenal disorder
- 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
- Abuse of alcohol
- Dialysis or renal failure
- Known eGFR <60%
Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
Sites / Locations
- Stanford University
- Stanford
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fiasp then Novolog
Novolog then Fiasp
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl
Measured as percentage of time in range (days).
Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl
Percentage of time in range (days) as a measure of hypoglycemia.
Secondary Outcome Measures
Mean Sensor Glucose in mg/dl
Mean sensor data over the second week of using a randomized, blinded insulin.
Full Information
NCT ID
NCT03554486
First Posted
May 31, 2018
Last Updated
August 16, 2021
Sponsor
Stanford University
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT03554486
Brief Title
Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
Official Title
Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy: To Assess How the 670G System Adapts to the Introduction of Fiasp® Insulin
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantInvestigator
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fiasp then Novolog
Arm Type
Experimental
Arm Description
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.
Arm Title
Novolog then Fiasp
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fiasp
Other Intervention Name(s)
Fast Acting Insulin Aspart
Intervention Description
Fiasp insulin will be used for 2 weeks with the 670G hybrid closed-loop system
Intervention Type
Drug
Intervention Name(s)
Novolog
Other Intervention Name(s)
Insulin Aspart
Intervention Description
Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system
Primary Outcome Measure Information:
Title
Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl
Description
Measured as percentage of time in range (days).
Time Frame
7 days (during 2nd half of 2-week intervention period)
Title
Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl
Description
Percentage of time in range (days) as a measure of hypoglycemia.
Time Frame
7 days (during 2nd half of 2-week intervention period)
Secondary Outcome Measure Information:
Title
Mean Sensor Glucose in mg/dl
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
Age ≥18 years
Using Novolog or Fiasp® insulin at time of enrollment
Willing to use Fiasp® insulin
Total daily insulin dose is at least 0.3 units/kg/day
Usual carbohydrate intake is at least 60 grams a day, and willing to have at least 25 grams of carbohydrates for breakfast
For females, not currently known to be pregnant
An understanding of and willingness to follow the protocol and sign the informed consent
Willing to have photographs taken of their infusion sites
Willing to download their 670G pump every 1-2 weeks to a research Carelink account
Willingness to answer a brief online questionnaire every 2 weeks
Must be able to understand spoken or written English
For subjects participating in Part 2 of this study they will need to be using Fiasp® as part of their usual care
Hemoglobin A1c between 6 and 10% at the time of enrollment
Exclusion Criteria:
Pregnant or lactating females
No hypoglycemic seizure or loss of consciousness in the past 6 months
Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
No known cardiovascular events in the last 6 months
No active proliferative diabetic retinopathy
Known tape allergies
Current treatment for a seizure disorder
Cystic fibrosis
Active infection
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
Inpatient psychiatric treatment in the past 6 months
Presence of a known adrenal disorder
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
Abuse of alcohol
Dialysis or renal failure
Known eGFR <60%
Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Buckingham, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28918652
Citation
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.
Results Reference
background
PubMed Identifier
28055230
Citation
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.
Results Reference
background
PubMed Identifier
32520594
Citation
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.
Results Reference
background
Learn more about this trial
Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
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