Type1diabetes
Conditions
Brief summary
Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate.
Detailed description
The investigators hypothesize that RAI absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate during the clamp study will be significantly faster when insulin bolus is delivered using the Quick Bolus feature as compared to the Standard Bolus. Outcomes were updated at time of results entry.
Interventions
DEVICEQuick Bolus
Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via quick bolus of 15 units per minute during a euglycemic clamp.
DEVICEStandard Bolus
Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via standard bolus of 1.5 units per minute during a euglycemic clamp.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
single blinded
Intervention model description
This study will be a cross-over, randomized order, single blinded clinical study in subjects with Type 1 Diabetes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 - 30 (inclusive) 2. Clinical diagnosis of T1D of at least one year's duration 3. On Continuous Subcutaneous Insulin Infusion (CSII) therapy for at least three months 4. HbA1c \<10% 5. Minimum weight requirement of at least 37.9 kg 6. Ability to comprehend written and spoken English 7. Total daily requirement of insulin between 0.6 and1.2 U/kg/day 8. Not have any other medical condition or disease known to affect insulin action and glucose control aside from T1D or treated hypothyroidism
Exclusion criteria
1. Medication besides insulin known to alter blood glucose or insulin action 2. Female subjects of reproductive potential that are pregnant or breast feeding, or not consistently using a barrier method or abstinence as contraception. 3. Inability to comprehend written and spoken English 4. 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 5. Hematocrit less than 35% or a serum potassium less than 3.4 mmol/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Glucose Infusion Rate | 300 minutes | time to maximum glucose infusion rate (GIR) in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Earlier Clearance of Exogenous Insulin. | up to 5 hours | Time to reach baseline insulin concentrations is used to determine the completion of insulin as part bolus of bioavailability. |
| Maximum Glucose Infusion Rate | 300 minutes | maximum glucose infusion rate (GIRmax) |
| Area Under the Curve for the Glucose Infusion Rate | 300 minutes | area under the curve for the glucose infusion rate |
Countries
United States
Participant flow
Pre-assignment details
11 participants consented to participate but 2 were lost to follow up prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Individuals Given Standard Bolus First, Then Quick Bolus Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.
Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via quick bolus of 15 units per minute during a euglycemic clamp.
Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via standard bolus of 1.5 units per minute during a euglycemic clamp. | 5 |
| Individuals Given Quick Bolus First, Then Standard Bolus Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design.
Quick Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via quick bolus of 15 units per minute during a euglycemic clamp.
Standard Bolus: Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via standard bolus of 1.5 units per minute during a euglycemic clamp. | 3 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-19 Protocol | 0 | 1 |
Baseline characteristics
| Characteristic | Individuals Given Standard Bolus First, Then Quick Bolus | Total | Individuals Given Quick Bolus First, Then Standard Bolus |
|---|---|---|---|
| Age, Continuous | 22.8 years STANDARD_DEVIATION 3.3 | 22 years STANDARD_DEVIATION 3.2 | 20.7 years STANDARD_DEVIATION 3.1 |
| Baseline mean percent Hemoglobin A1c | 7.6 percent Hemoglobin A1c STANDARD_DEVIATION 1.3 | 7.7 percent Hemoglobin A1c STANDARD_DEVIATION 1.1 | 7.9 percent Hemoglobin A1c STANDARD_DEVIATION 1.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 2 Participants |
| Region of Enrollment United States | 5 participants | 8 participants | 3 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 1 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
Primary
Time to Maximum Glucose Infusion Rate
time to maximum glucose infusion rate (GIR) in minutes
Time frame: 300 minutes
Population: Complete case analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Quick Bolus | Time to Maximum Glucose Infusion Rate | 116.54 minutes |
| Standard Bolus | Time to Maximum Glucose Infusion Rate | 172.21 minutes |
95% CI: [-124.63, 13.3]Mixed Models Analysis
Secondary
Area Under the Curve for the Glucose Infusion Rate
area under the curve for the glucose infusion rate
Time frame: 300 minutes
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Quick Bolus | Area Under the Curve for the Glucose Infusion Rate | 1204.29 mg/kg |
| Standard Bolus | Area Under the Curve for the Glucose Infusion Rate | 1072.44 mg/kg |
95% CI: [-246.7, 510.41]Mixed Models Analysis
Secondary
Earlier Clearance of Exogenous Insulin.
Time to reach baseline insulin concentrations is used to determine the completion of insulin as part bolus of bioavailability.
Time frame: up to 5 hours
Population: Outcome was not part of the study protocol and therefore was not collected.
Secondary
Maximum Glucose Infusion Rate
maximum glucose infusion rate (GIRmax)
Time frame: 300 minutes
Population: Complete case analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Quick Bolus | Maximum Glucose Infusion Rate | 8.42 mg/kg/min |
| Standard Bolus | Maximum Glucose Infusion Rate | 7.45 mg/kg/min |
95% CI: [-1.1, 3.02]Mixed Models Analysis