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Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy

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ClinicalTrials.gov Identifier: NCT03554486
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Bruce A. Buckingham, Stanford University

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®.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Fiasp Drug: Novolog Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Group 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: Group 2
Group 2 will use Novolog insulin for 2 weeks, followed by Fiasp 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




Primary Outcome Measures :
  1. Percent of sensor glucose values between 70-180 mg/dl [ Time Frame: Seven Days - Last week of values for each arm of the study ]
    Measure of time in range

  2. Percent of sensor glucose readings <70 mg/dl [ Time Frame: Seven Days - Last week of values for each arm of the study ]
    Measure of hypoglycemia


Secondary Outcome Measures :
  1. Mean sensor glucose in mg/dl [ Time Frame: Seven days - last week of values for each arm of the study ]
    Mean sensor glucose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Locations
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United States, California
Stanford University
Palo Alto, California, United States, 94304
Stanford
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
Medtronic
Investigators
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Principal Investigator: Bruce Buckingham, MD Stanford University

Publications:
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Responsible Party: Bruce A. Buckingham, Professor of Pediatric Endocrinology, Stanford University
ClinicalTrials.gov Identifier: NCT03554486     History of Changes
Other Study ID Numbers: 46202
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs