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    Clinical Trial Results:
    Assessment of the Hydraulic Tissue Resistance at the Site of Subcutaneous Insulin Infusion in Patients with Type 1 Diabetes

    Summary
    EudraCT number
    		 2015-005311-32
    Trial protocol
    		 AT  
    Global end of trial date
    06 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Nov 2021
    First version publication date
    22 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RHEO-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz
    Sponsor organisation address
    Auenbruggerplatz 15, Graz, Austria, A-8036
    Public contact
    Center for Medical Research (ZMF), Medical University of Graz; Dept. of Internal Medicine; Division of Endocrinology and Diabetology, +43 31638572831, werner.regittnig@medunigraz.at
    Scientific contact
    Center for Medical Research (ZMF), Medical University of Graz; Dept. of Internal Medicine; Division of Endocrinology and Diabetology, +43 31638572831, werner.regittnig@medunigraz.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 May 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Apr 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study was to monitor the tissue hydraulic resistance at the subcutaneous tissue sites of infusion of an insulin and insulin-free solution in patients with type 1 diabetes and to determine the frequency distributions of the tissue hydraulic resistance at these infusion sites over a time period of 7 days.
    Protection of trial subjects
    Subjects were individually instructed on the use of the insulin pump employed in the study. Subjects were given written instructions for handling low and high glucose concentrations. Subjects were provided with a 24-hour telephone helpline. Subjects were asked to perform at least seven blood glucose measurements per day and to immediately contact the study team when correction boluses failed to decrease their glucose levels.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jan 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the diabetes out-patient clinics of the Medical University of Graz. Recruitment period lasted from January 2016 to April 2016

    Pre-assignment
    Screening details
    		 35 subjects were screened. They were of both sexes, in the age group of 18–65 years and diagnosed with type 1 diabetes. They had to have HbA1C values of <10%, and had to be treated with continuous subcutaneous insulin Infusion (insulin pump therapy). Five subjects were excluded due to screening failures.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Insulin Infusion Sites
    Arm description
    		 Subjects wore two identical insulin pumps over a period of 7 days. One pump was used for continuous subcutaneous insulin infusion (CSII) therapy and the other for the infusion of an insulin-free solution. At both infusion sites, the tissue flow resistance (TFR) was assessed shortly after establishing the infusion sites (Day 0) and on each of the 7 subsequent days (Days 1-7).
    Arm type
    		 experimental, single arm

    Investigational medicinal product name
    Insulin Aspart
    Investigational medicinal product code
    SUB08195MIG
    Other name
    NovoRapid
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One insulin pump provided insulin aspart to the patient's body at basal and bolus rates. Basal insulin was continuously delivered throughout the day to mimic the background insulin production of the pancreas. Bolus insulin was delivered on demand to match the amount of carbohydrates ingested or to correct high blood glucose. The size of the basal and bolus insulin delivered was dependent on the patient's insulin sensitivity, the current blood glucose value, and total grams of carbohydrates that the patient ingested. The average daily total dose of insulin aspart administered in the study subjects was 45 insulin units.

    Number of subjects in period 1
    		Insulin Infusion Sites
    Started
    30
    Completed
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study (overall period)
    Reporting group description
    		 The reporting group data set includes the tissue flow resistances and infusion pressures observed at the insulin infusion sites. As all data sets followed a log-normal distribution, all data are presented as the geometric mean times-divide one geometric standard deviation (geoMean*/geoSD).

    Reporting group values
    		 Overall Study (overall period) Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 30 30
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.5 ( 12.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 22 22

    End points

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    End points reporting groups
    Reporting group title
    Insulin Infusion Sites
    Reporting group description
    		 Subjects wore two identical insulin pumps over a period of 7 days. One pump was used for continuous subcutaneous insulin infusion (CSII) therapy and the other for the infusion of an insulin-free solution. At both infusion sites, the tissue flow resistance (TFR) was assessed shortly after establishing the infusion sites (Day 0) and on each of the 7 subsequent days (Days 1-7).

    Subject analysis set title
    Placebo Infusion Sites
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This subject analysis set includes the tissue flow resistances and infusion pressures observed at the placebo infusion sites. As all data sets followed a log-normal distribution, all data are presented as the geometric mean times-divide one geometric standard deviation (geoMean*/geoSD).

    Primary: Tissue Flow Resistance on Day 7 of Infusion Site Use

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    End point title
    		 Tissue Flow Resistance on Day 7 of Infusion Site Use
    End point description
    End point type
    Primary
    End point timeframe
    Tissue flow resistance (TFR) observed at the infusion sites on the last study day (Day 7). TFR was computed from the infusion pressure time courses measured on Day 7.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa*s/µL
        geometric mean (standard deviation)
    8.64 ( 3.48 )
    0.43 ( 6.01 )
    Statistical analysis title
    		 TFR Day7 - insulin versus placebo infusion sites
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2-sided
    Confidence interval

    Secondary: Tissue Flow Resistance on Day 6 of Infusion Site Use

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    End point title
    		 Tissue Flow Resistance on Day 6 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Tissue flow resistance (TFR) observed at the infusion sites on Day 6. TFR was computed from the infusion pressure time courses measured on Day 6.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa*s/µL
        geometric mean (standard deviation)
    7.14 ( 3.38 )
    0.31 ( 7.89 )
    Statistical analysis title
    		 TFR Day 6 - insulin versus placebo infusion sites
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval
    Notes
    [1] - Analysis was performed using paired t-test on log-transformed data

    Secondary: Tissue Flow Resistance on Day 5 of Infusion Site Use

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    End point title
    		 Tissue Flow Resistance on Day 5 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Tissue flow resistance (TFR) observed at the infusion sites on Day 5. TFR was computed from the infusion pressure time courses measured on Day 5.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa*s/µL
        geometric mean (standard deviation)
    4.40 ( 6.01 )
    0.50 ( 6.37 )
    Statistical analysis title
    		 TFR Day 5 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Tissue Flow Resistance on Day 4 of Infusion Site Use

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    End point title
    		 Tissue Flow Resistance on Day 4 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Tissue flow resistance (TFR) observed at the infusion sites on Day 4. TFR was computed from the infusion pressure time courses measured on Day 4.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa*s/µL
        geometric mean (standard deviation)
    4.38 ( 4.12 )
    0.32 ( 8.26 )
    Statistical analysis title
    		 TFR Day 4 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Tissue Flow Resistance on Day 3 of Infusion Site Use

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    End point title
    		 Tissue Flow Resistance on Day 3 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Tissue flow resistance (TFR) observed at the infusion sites on Day 3. TFR was computed from the infusion pressure time courses measured on Day 3.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa*s/µL
        geometric mean (standard deviation)
    2.48 ( 6.66 )
    0.29 ( 8.45 )
    Statistical analysis title
    		 TFR Day 3 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Tissue Flow Resistance on Day 2 of Infusion Site Use

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    End point title
    		 Tissue Flow Resistance on Day 2 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Tissue flow resistance (TFR) observed at the infusion sites on Day 2. TFR was computed from the infusion pressure time courses measured on Day 2.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa*s/µL
        geometric mean (standard deviation)
    1.32 ( 5.30 )
    0.35 ( 7.76 )
    Statistical analysis title
    		 TFR Day 2 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Tissue Flow Resistance on Day 1 of Infusion Site Use

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    End point title
    		 Tissue Flow Resistance on Day 1 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Tissue flow resistance (TFR) observed at the infusion sites on Day 1. TFR was computed from the infusion pressure time courses measured on Day 1.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa*s/µL
        geometric mean (standard deviation)
    0.73 ( 3.38 )
    0.22 ( 7.38 )
    Statistical analysis title
    		 TFR Day 1 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Tissue Flow Resistance on Day 0 of Infusion Site Use

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    End point title
    		 Tissue Flow Resistance on Day 0 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Tissue flow resistance (TFR) observed at the infusion sites on Day 0. TFR was computed from the infusion pressure time courses measured on Day 0
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa*s/µL
        geometric mean (standard deviation)
    0.42 ( 4.46 )
    0.49 ( 4.52 )
    Statistical analysis title
    		 TFR Day 0 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.68
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Maximum Infusion Pressure on Day 7 of Infusion Site Use

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    End point title
    		 Maximum Infusion Pressure on Day 7 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Maximum Infusion Pressure (Pmax) observed at the infusion sites on the last day of infusion site use (Day 7).
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    25.8 ( 2.11 )
    8.4 ( 1.42 )
    Statistical analysis title
    		 Pmax Day 7 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Maximum Infusion Pressure on Day 6 of Infusion Site Use

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    End point title
    		 Maximum Infusion Pressure on Day 6 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Maximum Infusion Pressure (Pmax) observed at the infusion sites on Day 6 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    23.0 ( 1.84 )
    8.5 ( 1.63 )
    Statistical analysis title
    		 Pmax Day 6 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Maximum Infusion Pressure on Day 5 of Infusion Site Use

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    End point title
    		 Maximum Infusion Pressure on Day 5 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Maximum Infusion Pressure (Pmax) observed at the infusion sites on Day 5 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    19.7 ( 1.94 )
    8.8 ( 1.59 )
    Statistical analysis title
    		 Pmax Day 5 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Maximum Infusion Pressure on Day 4 of Infusion Site Use

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    End point title
    		 Maximum Infusion Pressure on Day 4 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Maximum Infusion Pressure (Pmax) observed at the infusion sites on Day 4 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    17.5 ( 1.84 )
    8.0 ( 1.60 )
    Statistical analysis title
    		 Pmax Day 4 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Maximum Infusion Pressure on Day 3 of Infusion Site Use

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    End point title
    		 Maximum Infusion Pressure on Day 3 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Maximum Infusion Pressure (Pmax) observed at the infusion sites on Day 3 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    14.1 ( 1.90 )
    7.9 ( 1.55 )
    Statistical analysis title
    		 Pmax Day 3 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Maximum Infusion Pressure on Day 2 of Infusion Site Use

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    End point title
    		 Maximum Infusion Pressure on Day 2 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Maximum Infusion Pressure (Pmax) observed at the infusion sites on Day 2 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    11.5 ( 1.58 )
    8.5 ( 1.65 )
    Statistical analysis title
    		 Pmax Day 2 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.006
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Maximum Infusion Pressure on Day 1 of Infusion Site Use

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    End point title
    		 Maximum Infusion Pressure on Day 1 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Maximum Infusion Pressure (Pmax) observed at the infusion sites on Day 1 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    8.7 ( 1.56 )
    7.5 ( 1.53 )
    Statistical analysis title
    		 Pmax Day 1 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.061
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Maximum Infusion Pressure on Day 0 of Infusion Site Use

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    End point title
    		 Maximum Infusion Pressure on Day 0 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Maximum Infusion Pressure (Pmax) observed at the infusion sites on Day 0 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    7.4 ( 1.56 )
    7.2 ( 1.61 )
    Statistical analysis title
    		 Pmax Day 0 - insulin versus placebo infusion sites
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.696
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Mean Infusion Pressure on Day 7 of Infusion Site Use

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    End point title
    		 Mean Infusion Pressure on Day 7 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Average Infusion Pressure (Pmean) observed at the infusion sites on the last day of infusion site use (Day 7).
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    15.5 ( 2.35 )
    3.7 ( 1.69 )
    Statistical analysis title
    		 Pmean Day 7 - insulin versus placebo infusion site
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Mean Infusion Pressure on Day 6 of Infusion Site Use

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    End point title
    		 Mean Infusion Pressure on Day 6 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Average Infusion Pressure (Pmean) observed at the infusion sites on Day 6 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    13.5 ( 2.10 )
    3.7 ( 1.80 )
    Statistical analysis title
    		 Pmean Day 6 - insulin versus placebo infusion site
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Mean Infusion Pressure on Day 5 of Infusion Site Use

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    End point title
    		 Mean Infusion Pressure on Day 5 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Average Infusion Pressure (Pmean) observed at the infusion sites on Day 5 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    11.7 ( 2.31 )
    4.0 ( 1.78 )
    Statistical analysis title
    		 Pmean Day 5 - insulin versus placebo infusion site
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Mean Infusion Pressure on Day 4 of Infusion Site Use

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    End point title
    		 Mean Infusion Pressure on Day 4 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Average Infusion Pressure (Pmean) observed at the infusion sites on Day 4 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    10.7 ( 2.20 )
    3.7 ( 1.77 )
    Statistical analysis title
    		 Pmean Day 4 - insulin versus placebo infusion site
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Mean Infusion Pressure on Day 3 of Infusion Site Use

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    End point title
    		 Mean Infusion Pressure on Day 3 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Average Infusion Pressure (Pmean) observed at the infusion sites on Day 3 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    8.5 ( 2.28 )
    3.6 ( 1.67 )
    Statistical analysis title
    		 Pmean Day 3 - insulin versus placebo infusion site
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Mean Infusion Pressure on Day 2 of Infusion Site Use

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    End point title
    		 Mean Infusion Pressure on Day 2 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Average Infusion Pressure (Pmean) observed at the infusion sites on Day 2 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    5.9 ( 1.98 )
    3.8 ( 1.75 )
    Statistical analysis title
    		 Pmean Day 2 - insulin versus placebo infusion site
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Mean Infusion Pressure on Day 1 of Infusion Site Use

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    End point title
    		 Mean Infusion Pressure on Day 1 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Average Infusion Pressure (Pmean) observed at the infusion sites on Day 1 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    4.1 ( 1.54 )
    3.2 ( 1.59 )
    Statistical analysis title
    		 Pmean Day 1 - insulin versus placebo infusion site
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.041
    Method
    		 paired t-test 2 sided
    Confidence interval

    Secondary: Mean Infusion Pressure on Day 0 of Infusion Site Use

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    End point title
    		 Mean Infusion Pressure on Day 0 of Infusion Site Use
    End point description
    End point type
    Secondary
    End point timeframe
    Average Infusion Pressure (Pmean) observed at the infusion sites on Day 0 of infusion site use.
    End point values
    		 Insulin Infusion Sites Placebo Infusion Sites
    Number of subjects analysed
    30
    30
    Units: kPa
        geometric mean (standard deviation)
    3.4 ( 1.58 )
    3.7 ( 1.69 )
    Statistical analysis title
    		 Pmean Day 0 - insulin versus placebo infusion site
    Statistical analysis description
    Analysis was performed using paired t-test on log-transformed data.
    Comparison groups
    Insulin Infusion Sites v Placebo Infusion Sites
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.62
    Method
    		 paired t-test 2 sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from the onset of screening to the last patient last visit
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 30 (36.67%)
    General disorders and administration site conditions
    insulin leakage from infusion site
         subjects affected / exposed
    7 / 30 (23.33%)
         occurrences all number
    7
    catheter malpositioning
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34739179
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