Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")

• Sponsor: Capillary Biomedical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04398030
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), AMCR Institute (Other), Integrated Medical Development (Industry)
• Enrollment: 7
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.2
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1; Type 1 Diabetes	Device: coil-reinforced soft polymer indwelling cannula; Device: soft Teflon indwelling catheter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• 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
• Actual Study Start Date: Jul 17, 2020
• Actual Primary Completion Date: Apr 22, 2021
• Actual Study Completion Date: Apr 22, 2021

Arms and Interventions

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.	Device: coil-reinforced soft polymer indwelling cannula; 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.	Device: soft Teflon indwelling catheter; Insulin infusion set will be used for up to 7 days of continuous use or until failure

Outcome Measures

Primary Outcome Measures

1. 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))]. [7 days]

   The primary endpoint will be compared between the treatment groups.

Secondary Outcome Measures

1. Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-Maximum Insulin Concentration (Tmax) [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.

2. Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Maximum Insulin Concentration (Cmax) [7 days]

   Cmax is the maximum insulin concentration between t=0 (bolus) and t=300 minutes.

3. Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Early) Maximum Insulin Concentration [t50%(Early)] [7 days]

   The time to half-maximal insulin concentration- early (before peak)

4. Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Mean-residence Time (MRT) of Insulin [7 days]

   Mean residence time quantifies the sum of average absorption time and average systemic residence time.

5. Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Area Under the Curve (AUC0-300) [7 days]

   The area under the insulin concentration curve until 300 minutes after bolus administration

6. Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Insulin Early Exposure: AUC0-60 [7 days]

   Area under the insulin concentration curve in the first 60 minutes after bolus administration

7. Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Late) Maximum Insulin Concentration [t50%(Late)] [7 days]

   Time at which 50% of the maximum insulin concentration was reached.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Participants are 18 - 70 years of age inclusive

2. Participant is in generally good health, as determined by the investigator

3. Participant is willing and able to individually complete written informed consent and agrees to comply with all study related testing and examinations

4. 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

5. Participant has been diagnosed with T1DM for at least 12 months

6. C-peptide <0.6 nmol/L at screening

7. 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.

8. Participant can provide a minimum of 14 days of insulin pump data to demonstrate pump use compliance

9. 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.

10. 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

11. Participant has BMI in the range 20 - 35 kg/m2 inclusive

12. Participant has experience infusing a rapid-acting insulin analog for at least 6 months

13. 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.

14. Participant has ability to understand and comply with protocol procedures and to provide informed consent

15. HbA1c ≤8.5%

16. 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:

1. 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)

2. Participants who routinely change their commercial insulin infusion sets on average less often than every 4.5 days

3. Female participant is pregnant or nursing

4. Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)

5. Participant has hemoglobin <12.0 g/dL or potassium < 3.5 milliequivalent/L at screening

6. 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.

7. Participant has a history of diabetic ketoacidosis in the last 6 months

8. Participant has known cardiovascular disease considered to be clinically relevant by the investigator

9. Participant has known arrhythmias considered to be clinically relevant by the investigator

10. Participant has known history of:

11. Cushing's Disease,

12. Pancreatic islet cell tumor, or

13. Insulinoma

14. Participant has:

15. Lipodystrophy,

16. Extensive lipohypertrophy, as assessed by the investigator

17. Participant is undergoing current treatment with:

18. Systemic oral or intravenous corticosteroids,

19. Monoamine oxidase (MAO) inhibitors,

20. Non-selective systemic beta-blockers,

21. Growth hormone,

22. Thyroid hormones, unless use has been stable during the past 3 months

23. SGLT2 inhibitors

24. 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:

25. Alcoholism,

26. Drug abuse

27. Significant acute or chronic illness, that in the investigator's opinion, might interfere with participant safety or integrity of study results

28. Planned operation, MRI or CT which require removal of infusion set or CGM sensor during wear periods

29. 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.

30. Current participation in another clinical drug or device study

31. Inability of the participant to comply with all study procedures or to understand the participant instructions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AMCR Institute	Escondido	California	United States	92025

Sponsors and Collaborators

• Capillary Biomedical, Inc.
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• AMCR Institute
• Integrated Medical Development

Investigators

• Principal Investigator: Timothy Bailey, MD, AMCR Institute

Study Documents (Full-Text)

• Study Protocol - Nov 24, 2020
• Statistical Analysis Plan - Jun 20, 2021

More Information

Additional Information:

• Site link which allows for the participant to enter information for the site to identify possible studies for participant enrollment

Publications

None provided.

• Responsible Party: Capillary Biomedical, Inc.
• ClinicalTrials.gov Identifier: NCT04398030
• Other Study ID Numbers: 150-1022-00; 2R44DK110969-02
• First Posted: May 21, 2020
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Coil-Reinforced Soft Polymer Indwelling Cannula Then Soft Teflon Indwelling Cannula	Soft Teflon Indwelling Cannula Then Coil-Reinforced Soft Polymer Indwelling Cannula
Arm/Group Description	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	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
Period Title: Treatment Period 1 (1 Week)
STARTED	3	4
COMPLETED	3	3
NOT COMPLETED	0	1
Period Title: Treatment Period 1 (1 Week)
STARTED	3	3
COMPLETED	3	3
NOT COMPLETED	0	0
Period Title: Treatment Period 1 (1 Week)
STARTED	3	3
COMPLETED	2	3
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	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.
Overall Participants	7
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.2 (9.24)
Sex: Female, Male (Count of Participants)
Female	2 28.6%
Male	5 71.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	7 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 14.3%
Native Hawaiian or Other Pacific Islander	1 14.3%
Black or African American	1 14.3%
White	4 57.1%
More than one race	0 0%
Unknown or Not Reported	0 0%
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	27.6 (3.81)

Outcome Measures

1. Primary Outcome

Title	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))].
Description	The primary endpoint will be compared between the treatment groups.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population

Arm/Group Title	Coil-reinforced Soft Polymer Indwelling Cannula	Soft Teflon Indwelling Cannula
Arm/Group Description	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	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
Measure Participants	6	6
Mean (95% Confidence Interval) [Slope]	-0.102	-0.097

2. Secondary Outcome

Title	Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-Maximum Insulin Concentration (Tmax)
Description	The Time-to-Maximum Glucose Infusion (GIR) rate, tmax (GIR) is the minute between the time corresponding to the GIR max and Time 0.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Coil-reinforced Soft Polymer Indwelling Cannula	Soft Teflon Indwelling Cannula
Arm/Group Description	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	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
Measure Participants	6	6
Day 0	65.8 (30.07)	67.5 (25.05)
Day 7	25.0 (7.07)	31.0 (16.73)

3. Secondary Outcome

Title	Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Maximum Insulin Concentration (Cmax)
Description	Cmax is the maximum insulin concentration between t=0 (bolus) and t=300 minutes.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Coil-reinforced Soft Polymer Indwelling Cannula	Soft Teflon Indwelling Cannula
Arm/Group Description	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	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
Measure Participants	6	6
Day 0	57.8 (21.51)	62.3 (20.94)
Day 7	86.6 (23.95)	96.9 (49.12)

4. Secondary Outcome

Title	Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Early) Maximum Insulin Concentration [t50%(Early)]
Description	The time to half-maximal insulin concentration- early (before peak)
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Coil-reinforced Soft Polymer Indwelling Cannula	Soft Teflon Indwelling Cannula
Arm/Group Description	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	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
Measure Participants	6	6
Day 0	22.8 (11.34)	29.1 (10.59)
Day 7	11.5 (4.13)	14.8 (5.21)

5. Secondary Outcome

Title	Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Mean-residence Time (MRT) of Insulin
Description	Mean residence time quantifies the sum of average absorption time and average systemic residence time.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Coil-reinforced Soft Polymer Indwelling Cannula	Soft Teflon Indwelling Cannula
Arm/Group Description	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	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
Measure Participants	6	6
Day 0	121.8 (25.10)	117.7 (27.08)
Day 7	77.4 (8.92)	75.9 (14.07)

6. Secondary Outcome

Title	Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Area Under the Curve (AUC0-300)
Description	The area under the insulin concentration curve until 300 minutes after bolus administration
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Coil-reinforced Soft Polymer Indwelling Cannula	Soft Teflon Indwelling Cannula
Arm/Group Description	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	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
Measure Participants	6	6
Day 0	9084 (2826)	8982 (1453)
Day 7	6920 (1908)	7313 (2483)

7. Secondary Outcome

Title	Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Insulin Early Exposure: AUC0-60
Description	Area under the insulin concentration curve in the first 60 minutes after bolus administration
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Coil-reinforced Soft Polymer Indwelling Cannula	Soft Teflon Indwelling Cannula
Arm/Group Description	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	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
Measure Participants	6	6
Day 0	2131 (923.1)	2200 (940.6)
Day 7	3626 (922.9)	3840 (2055)

8. Secondary Outcome

Title	Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Late) Maximum Insulin Concentration [t50%(Late)]
Description	Time at which 50% of the maximum insulin concentration was reached.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Coil-reinforced Soft Polymer Indwelling Cannula	Soft Teflon Indwelling Cannula
Arm/Group Description	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	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
Measure Participants	6	6
Day 0	156.8 (34.13)	156.5 (44.47)
Day 7	67.8 (13.20)	76.3 (28.87)

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Coil-reinforced Soft Polymer Indwelling Cannula		Soft Teflon Indwelling Cannula
Arm/Group Description	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		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
All Cause Mortality
	Coil-reinforced Soft Polymer Indwelling Cannula		Soft Teflon Indwelling Cannula
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/7 (0%)
Serious Adverse Events
	Coil-reinforced Soft Polymer Indwelling Cannula		Soft Teflon Indwelling Cannula
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Coil-reinforced Soft Polymer Indwelling Cannula		Soft Teflon Indwelling Cannula
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/6 (50%)		2/7 (28.6%)
General disorders
Infusion Site Erythema	1/6 (16.7%)	1	1/7 (14.3%)	1
Infusion Site Induration	1/6 (16.7%)	1	0/7 (0%)	0
Infusion Site Edema	1/6 (16.7%)	1	1/7 (14.3%)	1
Infusion Site Pain	1/6 (16.7%)	2	1/7 (14.3%)	1
Metabolism and nutrition disorders
Hyperglycemia	1/6 (16.7%)	2	1/7 (14.3%)	1
Product Issues
Participant-Device Interaction Incompatibility	1/6 (16.7%)	3	0/7 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.