Recruiting

Fiasp vs. NovoLog

Sponsor:

Mountain Diabetes and Endocrine Center

Code:

NCT04414579

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Faster Insulin Aspart (Fiasp®)

Study Details

Brief summary:

The purpose of this investigator-initiated trial is to compare the efficacy in terms of time to recovery from hyperglycemia as measured by time to arrest of hyperglycemic excursion ("glucose plateau point", primary endpoint) and return to premeal glucose target if feasible (secondary endpoint) between Fiasp and conventional insulin aspart when used as a correction bolus. These endpoints will be determined by CGM (Dexcom) from data exported from the Dexcom Clarity program.

Conditions

Type 1 Diabetes Mellitus

Study ID

NCT04414579

Start date

Mar 27, 2019

Status verified date

Nov, 2020

Completion date

Mar, 2021

Anticipated

Primary completion date

Mar, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female patients > 18 years of age
  • Type 1 DM of > 1 year duration
  • Use of any open loop insulin pump, Tandem T-Slim with Basal IQ, Insulet Omnipod Dash, or any other investigator-approved insulin pumps with Dexcom CGM G5, G6, or newer version for > 6 months
  • Good baseline glycemic control (HbA1c < 7.5%; low risk of hypoglycemia by CGM as defined by Dexcom Clarity report)
  • No episodes of severe hypoglycemia in the previous 3 months
  • Pump download shows regular meal bolusing, accurate carbohydrate counting ability, and willingness to use exercise markers in Dexcom
  • CGM download shows regular use (>85% of time) and regular calibration if using G5 sensor (G6 requires no calibration)
  • Females using adequate contraception

Exclusion Criteria:

  • Use of CGM other than Dexcom G5 or G6 or a newer Dexcom CGM version
  • Suboptimal baseline glycemic control (HbA1c > 7.5%)
  • Pump or CGM download shows suboptimal use of devices (lack of meal boluses, frequent overrides of pump, excessive pump suspension, inadequate calibration or inconsistent usage of CGM)
  • Serious comorbidities including CVD with recent event, actively treated malignancy, renal dysfunction with eGFR < 45 ml/min, or any other condition which in the opinion of the investigator would preclude subject's ability to participate in trial
  • Females unwilling to use contraception, planning pregnancy or breastfeeding
  • Use of any other glucose-lowering agents than insulin
  • Hypersensitivity to insulin aspart or one of the excipients in faster insulin aspart
  • Known diabetic gastroparesis

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: No Intervention: Conventional Insulin Aspart (NovoLog®)

In the aspart group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses. Aspart is put into their pump and delivered to their body through a small tube placed under your skin. In this NovoLog®-only treatment group, the subject will take aspart with each meal while your pump also gives you a slow, continuous dose of aspart for basal insulin. This treatment group is very similar (or even identical) to the treatment the subject was receiving prior to starting the study.

active comparator: Faster Insulin Aspart (Fiasp®)

In the Fiasp group, the subject will only take aspart through the their pump. This study population will have an established expertise in diabetes self-management with previous knowledge of insulin pump therapy and Dexcom Continuous Glucose Monitoring (CGM). Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses. Fiasp is put into their pump and delivered to their body through a small tube placed under their skin. In this Fiasp treatment group, the subject will take fiasp with each meal while their pump also gives them a slow, continuous dose of aspart for basal insulin. This treatment group is very similar (or even identical) to the treatment the subject was receiving prior to starting the study.

Interventions

Faster Insulin Aspart (Fiasp®)

Subjects will be randomized either to use Fiasp or conventional insulin aspart in CSII. CSII settings (basal, bolus, and correction factors) will be optimized using a meal challenge for a 2-week run in period followed by a 10-week period of CSII use with the assigned insulin. After a 12-week maintenance period, each group will cross over to the other insulin (conventional insulin aspart or Fiasp) by CSII for a second 2-week optimization period followed by a 10-week treatment period.

Primary outcome measure

  • Time to stabilization of rising blood sugar by CGM after correction bolus [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Wendy S Lane, MD

8286849588mountaindiabetes@msn.com

Melinda L Buford, RN, BSN

8286849588mbuford@mdecresearch.com

Locations

Mountain Diabetes and Endocrine Center

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Melinda L Buford, RN, BSN

828-684-9588mbuford@mdecresearch.com

More Information

Sponsor

Mountain Diabetes and Endocrine Center

Last update posted

Nov 24, 2020

Last verified

Nov, 2020

Keywords

  • continuous glucose monitoring
  • continuous subcutaneous insulin infusion
  • hyperglycemia
  • correction bolus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mountain Diabetes and Endocrine Center on 2020-11-24.