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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44DK110969-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| AMCR Institute | OTHER |
| Integrated Medical Development | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coil-reinforced soft polymer indwelling cannula | Device | Insulin infusion set will be used for up to 7 days of continuous use or until failure |
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| 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))]. | The primary endpoint will be compared between the treatment groups. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
| Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Maximum Insulin Concentration (Cmax) |
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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:
Participant has:
Participant is undergoing current treatment with:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Bailey, MD | AMCR Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36342853 | Derived | 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. |
| Label | URL |
|---|---|
| Site link which allows for the participant to enter information for the site to identify possible studies for participant enrollment | View source |
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Study participants were recruited from the existing Type 1 diabetes database at the study center and from referrals from other diabetes treatment clinics in surrounding areas.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coil-Reinforced Soft Polymer Indwelling Cannula Then Soft Teflon 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. Coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 (1 Week) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2020 | Jun 9, 2022 |
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| soft Teflon indwelling catheter | Device | Insulin infusion set will be used for up to 7 days of continuous use or until failure |
|
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)] | 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 | 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) | 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 | 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 at which 50% of the maximum insulin concentration was reached. | 7 days |
| FG001 | Soft Teflon Indwelling Cannula Then Coil-Reinforced Soft Polymer 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. Soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure |
| COMPLETED |
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| NOT COMPLETED |
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| Washout (2 Weeks) |
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| Treatment Period 2 (1 Week) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants were randomized to either the soft Teflon indwelling cannula group or the coil-reinforced soft polymer indwelling cannula group in treatment period 1. Then after a 2-week washout/rest (±1 week), participants crossed over into treatment period 2 using either the soft Teflon indwelling cannula or the coil-reinforced soft polymer indwelling cannula. The participant wore each infusion set up to 7 consecutive days in each treatment period. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to Treat (ITT) population | Posted | Mean | 95% Confidence Interval | Slope | 7 days |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | min | 7 days |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | mU/L | 7 days |
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| Secondary | 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) | ITT population | Posted | Mean | Standard Deviation | min | 7 days |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | min | 7 days |
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| Secondary | 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 | ITT Population | Posted | Mean | Standard Deviation | mU*min/L | 7 days |
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| Secondary | 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 | ITT population | Posted | Mean | Standard Deviation | mU*min/L | 7 days |
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| Secondary | 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. | ITT population | Posted | Mean | Standard Deviation | min | 7 days |
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4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure | 0 | 6 | 0 | 6 | 3 | 6 |
| EG001 | 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. soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure | 0 | 7 | 0 | 7 | 2 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion Site Erythema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Infusion Site Induration | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Infusion Site Edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Infusion Site Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Participant-Device Interaction Incompatibility | Product Issues | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alayne Lehman Director of Clinical Affairs | Capillary BioMedical, Inc. | 949-317-1711 | alayne.lehman@capillarybio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2021 | Jun 9, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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