N/A
Completed N=9
The Effect of Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes
Type1diabetes
Source: ClinicalTrials.gov NCT03542682 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Time to Maximum Glucose Infusion Rate — 116.54; 172.21 minutes
Summary
Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Maximum Glucose Infusion Rate |
116.54; 172.21 | — |
| SECONDARY Earlier Clearance of Exogenous Insulin. |
— | — |
| SECONDARY Maximum Glucose Infusion Rate |
8.42; 7.45 | — |
| SECONDARY Area Under the Curve for the Glucose Infusion Rate |
1204.29; 1072.44 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 - 30 (inclusive)
- Clinical diagnosis of T1D of at least one year's duration
- On Continuous Subcutaneous Insulin Infusion (CSII) therapy for at least three months
- HbA1c <10%
- Minimum weight requirement of at least 37.9 kg
- Ability to comprehend written and spoken English
- Total daily requirement of insulin between 0.6 and1.2 U/kg/day
- Not have any other medical condition or disease known to affect insulin action and glucose control aside from T1D or treated hypothyroidism
Exclusion Criteria
- Medication besides insulin known to alter blood glucose or insulin action
- Female subjects of reproductive potential that are pregnant or breast feeding, or not consistently using a barrier method or abstinence as contraception.
- Inability to comprehend written and spoken English
- Any other condition, which in the judgment of the investigators, would interfere with the subject's ability to provide informed consent or the investigator's ability to perform the study
- Hematocrit less than 35% or a serum potassium less than 3.4 mmol/L
Data sourced from ClinicalTrials.gov (NCT03542682). 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.