Diabetes Mellitus, Type 1NCT04398030
Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")
A study testing coil-reinforced soft polymer indwelling cannula and soft Teflon indwelling catheter in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by Capillary Biomedical, Inc. at 1 site in United States.
Trial summary
This study has been designed as a prospectively enrolled, randomized sequence, 2-way crossover study of device performance, tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer indwelling cannula versus a commercial insulin infusion set using a soft Teflon indwelling… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Type 1 Diabetes
- What is being tested?
- coil-reinforced soft polymer indwelling cannula and soft Teflon indwelling catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2020to 22 Apr 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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%)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This study has been designed as a prospectively enrolled, randomized sequence, 2-way crossover study of device performance, tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer indwelling cannula versus a commercial insulin infusion set using a soft Teflon indwelling cannula, during two 7-day home use periods with 4 in-clinic euglycemic clamp sessions during each of the 7-day periods. After a wash-out period, subjects will cross over into the investigational or control group, respectively.
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes
- Being tested
- coil-reinforced soft polymer indwelling cannula, soft Teflon indwelling catheter
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coil-reinforced soft polymer indwelling cannulaDevice
Insulin infusion set will be used for up to 7 days of continuous use or until failure
soft Teflon indwelling catheterDevice
Insulin infusion set will be used for up to 7 days of continuous use or until failure
| Study group | Role | What they receive |
|---|---|---|
| coil-reinforced soft polymer indwelling cannula | Experimental | 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. Receives: Device: coil-reinforced soft polymer indwelling cannula |
| soft Teflon indwelling cannula | Active comparator | 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. Receives: Device: soft Teflon indwelling catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))].
The primary endpoint will be compared between the treatment groups.
Measured: 7 days
Secondary outcomes (7)
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-Maximum Insulin Concentration (Tmax)
The Time-to-Maximum Glucose Infusion (GIR) rate, tmax (GIR) is the minute between the time corresponding to the GIR max and Time 0.
Measured: 7 days
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Maximum Insulin Concentration (Cmax)
Cmax is the maximum insulin concentration between t=0 (bolus) and t=300 minutes.
Measured: 7 days
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Early) Maximum Insulin Concentration [t50%(Early)]
The time to half-maximal insulin concentration- early (before peak)
Measured: 7 days
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Mean-residence Time (MRT) of Insulin
Mean residence time quantifies the sum of average absorption time and average systemic residence time.
Measured: 7 days
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Area Under the Curve (AUC0-300)
The area under the insulin concentration curve until 300 minutes after bolus administration
Measured: 7 days
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Insulin Early Exposure: AUC0-60
Area under the insulin concentration curve in the first 60 minutes after bolus administration
Measured: 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 at which 50% of the maximum insulin concentration was reached.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start17 Jul 2020
- Primary completion22 Apr 2021
- Study completion22 Apr 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capillary Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), AMCR Institute, Integrated Medical Development
- Responsible party
- Sponsor
- Investigators
- Timothy Bailey, MD, Principal investigator, AMCR Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398030
- Sponsor's protocol ID
- 150-1022-00
- Other IDs
- 2R44DK110969-02
- Status last verified
- Aug 2022
- First submitted
- 8 May 2020
- Last updated
- 11 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kastner JR, Bailey TS, Strange P, Shi L, Oberg KA, Strasma PJ, Joseph JI, Muchmore DB. Progressive Acceleration of Insulin Exposure Over 7 Days of Infusion Set Wear. Diabetes Technol Ther. 2023 Feb;25(2):143-147. doi: 10.1089/dia.2022.0323. Epub 2022 Dec 20.
PubMed 36342853
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04398030
- Acronym / sponsor ID
- 150-1022-00
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Capillary Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), AMCR Institute, Integrated Medical Development
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 22 Apr 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 9 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has been designed as a prospectively enrolled, randomized sequence, 2-way crossover study of device performance, tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer indwelling cannula versus a commercial insulin infusion set using a soft Teflon indwelling cannula, during two 7-day home use periods with 4 in-clinic euglycemic clamp sessions during each of the 7-day periods. After a wash-out period, subjects will cross over into the investigational or control group, respectively.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coil-reinforced soft polymer indwelling cannula | Experimental | Device: coil-reinforced soft polymer indwelling cannulaParticipants 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. |
| soft Teflon indwelling cannula | Active comparator | Device: soft Teflon indwelling catheterParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (32 listed)
- 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)
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 |
|---|---|---|
| coil-reinforced soft polymer indwelling cannulaInsulin infusion set will be used for up to 7 days of continuous use or until failure | Device | coil-reinforced soft polymer indwelling cannula |
| soft Teflon indwelling catheterInsulin infusion set will be used for up to 7 days of continuous use or until failure | Device | soft Teflon indwelling cannula |
Primary outcome
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 secondary outcomes
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-Maximum Insulin Concentration (Tmax)
Time frame: 7 days
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Maximum Insulin Concentration (Cmax)
Time frame: 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
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Mean-residence Time (MRT) of Insulin
Time frame: 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
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Insulin Early Exposure: AUC0-60
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36342853Kastner JR, Bailey TS, Strange P, Shi L, Oberg KA, Strasma PJ, Joseph JI, Muchmore DB. Progressive Acceleration of Insulin Exposure Over 7 Days of Infusion Set Wear. Diabetes Technol Ther. 2023 Feb;25(2):143-147. doi: 10.1089/dia.2022.0323. Epub 2022 Dec 20.
- Site link which allows for the participant to enter information for the site to identify possible studies for participant enrollmentLink provided by the sponsor.
- 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.
Timothy Bailey, MD principal investigator
AMCR Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coil-reinforced soft polymer indwelling cannula and soft Teflon indwelling catheter in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by Capillary Biomedical, Inc. 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 17 inclusion and 32 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 11 Aug 2022. 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 9 Aug 2022). 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398030, which also lists 1 linked publication.
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 11 Aug 2022.