Phase 4
Completed N=24
Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03554486 ↗
Enrolled (actual)
24
Serious AEs
1.5%
Results posted
Aug 2021
Primary outcomePrimary: Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl — 78.4; 75.3 percentage of time — p=0.051
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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®.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl |
78.4; 75.3 | 0.051 |
| PRIMARY Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl |
2.3; 3.1 | 0.17 |
| SECONDARY Mean Sensor Glucose in mg/dl |
146; 147 | 0.74 |
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.
Data sourced from ClinicalTrials.gov (NCT03554486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.