Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03554486 |
Recruitment Status :
Completed
First Posted : June 13, 2018
Results First Posted : August 18, 2021
Last Update Posted : August 18, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 1 | Drug: Fiasp Drug: Novolog | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
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. |
Masking: | Double (Participant, Investigator) |
Masking Description: | Double-blinded |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 23, 2018 |
Actual Primary Completion Date : | March 30, 2019 |
Actual Study Completion Date : | March 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Fiasp then Novolog
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.
|
Drug: Fiasp
Fiasp insulin will be used for 2 weeks with the 670G hybrid closed-loop system
Other Name: Fast Acting Insulin Aspart Drug: Novolog Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system
Other Name: Insulin Aspart |
Experimental: Novolog then Fiasp
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.
|
Drug: Fiasp
Fiasp insulin will be used for 2 weeks with the 670G hybrid closed-loop system
Other Name: Fast Acting Insulin Aspart Drug: Novolog Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system
Other Name: Insulin Aspart |
- Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl [ Time Frame: 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 [ Time Frame: 7 days (during 2nd half of 2-week intervention period) ]Percentage of time in range (days) as a measure of hypoglycemia.
- Mean Sensor Glucose in mg/dl [ Time Frame: 7 days (during 2nd half of 2-week intervention period) ]Mean sensor data over the second week of using a randomized, blinded insulin.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554486
United States, California | |
Stanford University | |
Palo Alto, California, United States, 94304 | |
Stanford | |
Palo Alto, California, United States, 94305 |
Principal Investigator: | Bruce Buckingham, MD | Stanford University |
Documents provided by Bruce Buckingham, Stanford University:
Responsible Party: | Bruce Buckingham, Professor of Pediatric Endocrinology, Stanford University |
ClinicalTrials.gov Identifier: | NCT03554486 |
Other Study ID Numbers: |
46202 |
First Posted: | June 13, 2018 Key Record Dates |
Results First Posted: | August 18, 2021 |
Last Update Posted: | August 18, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin Insulin, Globin Zinc Insulin Aspart Insulin, Long-Acting Insulin degludec, insulin aspart drug combination Hypoglycemic Agents Physiological Effects of Drugs |