- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04398030
Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")
Randomized Crossover Euglycemic Clamp Study in Adult Patients With T1DM to Assess Pharmacokinetics and Pharmacodynamics of Subcutaneously Infused Insulin Using an Investigational Extended Wear Continuous Subcutaneous Insulin Infusion Cannula Compared to a Commercial Infusion Set
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Escondido, California, United States, 92025
- AMCR Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Participants are 18 - 70 years of age inclusive
- Participant is in generally good health, as determined by the investigator
- Participant is willing and able to individually complete written informed consent and agrees to comply with all study related testing and examinations
- Participant must be geographically stable (e.g., expects to be available and capable of returning for all study specified test and examinations) during the study period
- Participant has been diagnosed with T1DM for at least 12 months
- C-peptide <0.6 nmol/L at screening
- Participant has been using insulin pump therapy for at least 6 months and is currently using a Medtronic MiniMed pump, model series 530 or higher. Use of 670G in auto mode is acceptable.
- Participant can provide a minimum of 14 days of insulin pump data to demonstrate pump use compliance
- Participant is willing to perform frequent (4 times per day or more) self-monitoring of blood glucose (SMBG), including before meals and before bed, and using a meter and test strips provided by the sponsor during the two weeks of active treatment. This includes participants who are currently using real-time continuous glucose monitoring and may continue to do so, but must also collect SMBG values as instructed.
- Participant is willing to perform serum ketone measurements whenever the blood glucose is determined to be greater than 250 mg/dL after extended fasting (e.g. overnight or more than five hours after a meal) using a ketone meter and strips provided by the sponsor
- Participant has BMI in the range 20 - 35 kg/m2 inclusive
- Participant has experience infusing a rapid-acting insulin analog for at least 6 months
- Participant has been using or is willing to use a Continuous Glucose Monitor (CGM) (reading data available for at least 80% of time for a week of data collection during the screening period). Participants already using - Dexcom G6 real time CGM may continue to use their own CGM unit; participants not using the G6 will be provided with a G6 monitor. All participants will be provided with CGM disposables for use during the treatment period.
- Participant has ability to understand and comply with protocol procedures and to provide informed consent
- HbA1c ≤8.5%
- Stable body weight in the 3 months prior to enrollment (change in body weight <5%)
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Participants whose average total daily insulin dose exceeds 85 units/day (i.e., typically change insulin reservoirs more often than every 4 days on average)
- Participants who routinely change their commercial insulin infusion sets on average less often than every 4.5 days
- Female participant is pregnant or nursing
- Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)
- Participant has hemoglobin <12.0 g/dL or potassium < 3.5 milliequivalent/L at screening
- Participant has documented history in last 6 months of severe hypoglycemia associated with cognitive dysfunction sufficiently severe to require third party intervention or a history of impaired awareness of hypoglycemia.
- Participant has a history of diabetic ketoacidosis in the last 6 months
- Participant has known cardiovascular disease considered to be clinically relevant by the investigator
- Participant has known arrhythmias considered to be clinically relevant by the investigator
Participant has known history of:
- Cushing's Disease,
- Pancreatic islet cell tumor, or
- Insulinoma
Participant has:
- Lipodystrophy,
- Extensive lipohypertrophy, as assessed by the investigator
Participant is undergoing current treatment with:
- Systemic oral or intravenous corticosteroids,
- Monoamine oxidase (MAO) inhibitors,
- Non-selective systemic beta-blockers,
- Growth hormone,
- Thyroid hormones, unless use has been stable during the past 3 months
- SGLT2 inhibitors
Participant has significant history of any of the following, that in the opinion of the investigator would compromise the participant's safety or successful study participation:
- Alcoholism,
- Drug abuse
- Significant acute or chronic illness, that in the investigator's opinion, might interfere with participant safety or integrity of study results
- Planned operation, MRI or CT which require removal of infusion set or CGM sensor during wear periods
- Current treatment with systemic (oral or IV) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products that, in the opinion of the investigator, may alter insulin sensitivity or confer undue risk to the participant's participation in the study or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
- Current participation in another clinical drug or device study
- Inability of the participant to comply with all study procedures or to understand the participant instructions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DEVICE_FEASIBILITY
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: coil-reinforced soft polymer indwelling cannula
Participants in this arm are randomized into the coil-reinforced soft polymer indwelling cannula group and then switched to a soft Teflon indwelling cannula group after a 2-week washout/rest (±1 week).
The participant will try to wear each infusion set for 7 consecutive days.
|
Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
ACTIVE_COMPARATOR: soft Teflon indwelling cannula
Participants in this arm are randomized into the soft Teflon indwelling cannula group and then switched to the coil-reinforced soft polymer indwelling cannula group after a 2-week washout/rest (±1 week).
The participant will try to wear each infusion set for 7 consecutive days.
|
Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Primary Endpoint is the Rate of Decline (s) Over Wear Time (DOI, Day 3, Day 5, Day 7) of the Natural Logarithm of the Area Under the Glucose Infusion Rate Curve [ln (AUC0-300(GIR))].
Time Frame: 7 days
|
The primary endpoint will be compared between the treatment groups.
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-Maximum Insulin Concentration (Tmax)
Time Frame: 7 days
|
The Time-to-Maximum Glucose Infusion (GIR) rate, tmax (GIR) is the minute between the time corresponding to the GIR max and Time 0.
|
7 days
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Maximum Insulin Concentration (Cmax)
Time Frame: 7 days
|
Cmax is the maximum insulin concentration between t=0 (bolus) and t=300 minutes.
|
7 days
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Early) Maximum Insulin Concentration [t50%(Early)]
Time Frame: 7 days
|
The time to half-maximal insulin concentration- early (before peak)
|
7 days
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Mean-residence Time (MRT) of Insulin
Time Frame: 7 days
|
Mean residence time quantifies the sum of average absorption time and average systemic residence time.
|
7 days
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Area Under the Curve (AUC0-300)
Time Frame: 7 days
|
The area under the insulin concentration curve until 300 minutes after bolus administration
|
7 days
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Insulin Early Exposure: AUC0-60
Time Frame: 7 days
|
Area under the insulin concentration curve in the first 60 minutes after bolus administration
|
7 days
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Late) Maximum Insulin Concentration [t50%(Late)]
Time Frame: 7 days
|
Time at which 50% of the maximum insulin concentration was reached.
|
7 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150-1022-00
- 2R44DK110969-02 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 1
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
University of California, San FranciscoJuvenile Diabetes Research FoundationCompletedType 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMUnited States, Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
Spiden AGDCB Research AGRecruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Type 1 Diabetes Mellitus With HyperglycemiaSwitzerland
-
Hoffmann-La RocheRoche DiagnosticsCompletedDiabetes Mellitus Type 2, Diabetes Mellitus Type 1Germany
Clinical Trials on coil-reinforced soft polymer indwelling cannula
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia