Type1diabetesNCT03542682
The Effect of Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes
A study testing Quick Bolus and Standard Bolus in people with Type1diabetes, run by Yale University at 1 site in United States.
Trial summary
Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Quick Bolus and Standard Bolus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Insulin Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes
Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate.
Read the 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.
- Conditions
- Type1diabetes
- Being tested
- Quick Bolus, Standard Bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quick BolusDevice
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 BolusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals given Standard Bolus first, then quick bolus | Active comparator | Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. Receives: Device: Quick Bolus; Device: Standard Bolus |
| Individuals given Quick bolus first, then standard bolus | Active comparator | Individuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. Receives: Device: Quick Bolus; Device: Standard Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Maximum Glucose Infusion Rate
time to maximum glucose infusion rate (GIR) in minutes
Measured: 300 minutes
Secondary outcomes (3)
Earlier Clearance of Exogenous Insulin.
Time to reach baseline insulin concentrations is used to determine the completion of insulin as part bolus of bioavailability.
Measured: up to 5 hours
Maximum Glucose Infusion Rate
maximum glucose infusion rate (GIRmax)
Measured: 300 minutes
Area Under the Curve for the Glucose Infusion Rate
area under the curve for the glucose infusion rate
Measured: 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start30 May 2018
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will be a cross-over, randomized order, single blinded clinical study in subjects with Type 1 Diabetes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eda Cengiz, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542682
- Sponsor's protocol ID
- 2000022726
- Status last verified
- Jan 2024
- First submitted
- 30 Apr 2018
- Last updated
- 13 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Insulin Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03542682
- Acronym / sponsor ID
- 2000022726
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Posted 13 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be a cross-over, randomized order, single blinded clinical study in subjects with Type 1 Diabetes.
| Arm | Type | Receives |
|---|---|---|
| Individuals given Standard Bolus first, then quick bolus | Active comparator | Device: Quick Bolus, Device: Standard BolusIndividuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. |
| Individuals given Quick bolus first, then standard bolus | Active comparator | Device: Quick Bolus, Device: Standard BolusIndividuals with Type 1 Diabetes (T1D) will receive both Standard and Quick Bolus in a randomized cross-over design. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quick BolusIndividuals 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. | Device | Individuals given Quick bolus first, then standard bolus, Individuals given Standard Bolus first, then quick bolus |
| Standard BolusIndividuals 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. | Device | Individuals given Quick bolus first, then standard bolus, Individuals given Standard Bolus first, then quick bolus |
Primary outcome
Time to Maximum Glucose Infusion Rate
Time frame: 300 minutes
time to maximum glucose infusion rate (GIR) in minutes
3 secondary outcomes
Earlier Clearance of Exogenous Insulin.
Time frame: up to 5 hours
Maximum Glucose Infusion Rate
Time frame: 300 minutes
Area Under the Curve for the Glucose Infusion Rate
Time frame: 300 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eda Cengiz, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quick Bolus and Standard Bolus in people with Type1diabetes, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Maximum Glucose Infusion Rate (time frame: 300 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.