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    Clinical Trial Results:
    Prevention of Recurrent Severe Hypoglycaemia: a Definitive RCT Comparing Optimised MDI and CSII with or without Adjunctive Real-time Continuous Glucose Monitoring.

    Summary
    EudraCT number
    		 2009-015396-27
    Trial protocol
    		 GB  
    Global end of trial date
    03 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2016
    First version publication date
    04 Aug 2016
    Other versions
    Summary report(s)
    		 Hypocompass primary paper in Diabetes Care 2014

    Trial information

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    Trial identification
    Sponsor protocol code
    NCTU:ISRCTN52164803
    Additional study identifiers
    ISRCTN number
    		 ISRCTN52164803
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Sponsor organisation address
    Freeman Hospital, Freeman Road, Newcastle upon Tyne, United Kingdom, NE7 7ND
    Public contact
    Professor James Shaw, Newcastle University, jim.shaw@ncl.ac.uk
    Scientific contact
    Professor James Shaw, Newcastle University, jim.shaw@ncl.ac.uk
    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
    03 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to demonstrate that by optimising conventional management in people with type 1 diabetes mellitus complicated by severe hypoglycaemia, rigorous prevention of biochemical hypoglycaemia will restore hypoglycaemia awareness. This was an interventional multicentre prospective randomised controlled trial comparing hypoglycaemia avoidance with optimised subcutaneous insulin analogue regimen (MDI) and insulin pump therapy (CSII) with or without adjunctive real-time continuous subcutaneous glucose monitoring (RT) in a 2x2 factorial design. This randomised controlled trial was conducted in adults with type 1 diabetes and impaired awareness of hypoglycaemia (Gold Score >=4). Primary outcome was difference in 24-week Gold score.
    Protection of trial subjects
    Expected serious adverse events for this study are diabetic ketoacidosis requiring inpatient hospitalisation and hypoglycaemia requiring inpatient hospitalisation. Detailed review of all six episodes of DKA reported during the study provided supporting evidence that these were at least contributed to by inter current illness. Rates of Diabetic Ketoacidosis in all interventional arms were closely monitored by the DMC (given the potential for increased risk with the study insulin replacement regimens towards hypoglycaemia reduction). However, study data showed no increased risk.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jul 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 18 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 96
    Worldwide total number of subjects
    96
    EEA total number of subjects
    96
    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)
    88
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was a 24-week, multicentre, randomised, 2 x 2 factorial study at five UK tertiary-referral diabetes centres (Newcastle, Cambridge, Sheffield, Bournemouth and Plymouth). The recruitment period began on 1 March 2010 and was completed on 30 June 2011.

    Pre-assignment
    Screening details
    		 Patients were identified from clinics and research databases at each centre. Potential participants identified using the brief Hypoglycaemia Screening Questionnaire (hypoglycaemia history and Clarke/Edinburgh validated IAH questionnaires) to ascertain if they fulfilled severe hypoglycaemia/impaired awareness of hypoglycaemia inclusion criteria.

    Pre-assignment period milestones
    Number of subjects started
    		 110 [1]
    Intermediate milestone: Number of subjects
    Consent: 110
    Number of subjects completed
    		 96 [2]

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Withdrew pre-randomisation: 8
    Reason: Number of subjects
    		 C-peptide positive did not meet inclusion criteria: 6
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre-assignment period was a wash-in period, not all subjects completed the wash-in period and were randomised hence the difference in numbers.
    [2] - The number of subjects reported to be in the pre-assignment period is not consistent with the number starting period 1. It is expected that the number completing the pre-assignment period are also present in the arms in period 1.
    Justification: The pre-assignment period was a wash-in period, not all subjects completed the wash-in period and were randomised hence the difference in numbers.
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Multiple daily injections
    Arm description
    		 Multiple daily injections (Insulin group)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin Aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For the participants randomised to MDI (Multiple Daily Injections) Insulin Aspart will be given as follows: Formulation: 3 ml cartridge 100 Units/mL in a pre-filled pen (Flexpen). Dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long-acting insulin given at least once a day. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.

    Investigational medicinal product name
    Insulin Glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For the participants randomised to MDI the glargine will be given as follows: Formulation: 3 ml cartridge 100 Units/mL in a pre-filled pen (SoloStar). Lantus SoloStar is a pre-filled delivery device containing 3 mL insulin glargine. This device allows dose dialling in one-unit step increments between one unit and a maximum of 80 units. Lantus contains insulin glargine an insulin analogue with a prolonged duration of action. It should be administered once daily at any time but at the same time each day. The dosage and timing of dose of Lantus should be individually adjusted.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For the participants randomised to MDI (Multiple Daily injections) Insulin Aspart will be the rapid acting insulin analogue of choice. However for those patients who have had a previous negative experience or adverse effect with Insulin Aspart the alternative of insulin Lispro will be offered. Formulation: 3 ml cartridge 100 Units/mL in a pre-filled pen (Kwikpen). The dosage will be determined by the physician, according to the requirement of the patient.

    Arm title
    		 CSII
    Arm description
    		 Continuous subcutaneous insulin infusion (Insulin regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For participants randomised to CSII, insulin aspart will be the insulin used. Formulation: 10 ml vial 100 Units/mL. Dosing is individual and determined in accordance with the needs of the patient. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For patients who have had a previous negative experience or adverse effect with Insulin Aspart the alternative of Insulin Lispro will be offered. Insulin lispro for use in the CSII group will be provided in 10ml vials 100 Units/mL.

    Arm title
    		 SMBG
    Arm description
    		 Self-monitoring of blood glucose
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Real Time
    Arm description
    		 Real Time Monitoring
    Arm type
    		 Real Time Glucose Monitor

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Multiple daily injections CSII SMBG Real Time
    Started
    50
    46
    48
    48
    Completed
    50
    46
    48
    48
    Period 2
    Period 2 title
    24 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Multiple daily injections
    Arm description
    		 Multiple daily injections (Insulin group)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin Aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For the participants randomised to MDI (Multiple Daily Injections) Insulin Aspart will be given as follows: Formulation: 3 ml cartridge 100 Units/mL in a pre-filled pen (Flexpen). Dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long-acting insulin given at least once a day. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.

    Investigational medicinal product name
    Insulin Glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For the participants randomised to MDI the glargine will be given as follows: Formulation: 3 ml cartridge 100 Units/mL in a pre-filled pen (SoloStar). Lantus SoloStar is a pre-filled delivery device containing 3 mL insulin glargine. This device allows dose dialling in one-unit step increments between one unit and a maximum of 80 units. Lantus contains insulin glargine an insulin analogue with a prolonged duration of action. It should be administered once daily at any time but at the same time each day. The dosage and timing of dose of Lantus should be individually adjusted.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For the participants randomised to MDI (Multiple Daily injections) Insulin Aspart will be the rapid acting insulin analogue of choice. However for those patients who have had a previous negative experience or adverse effect with Insulin Aspart the alternative of insulin Lispro will be offered. Formulation: 3 ml cartridge 100 Units/mL in a pre-filled pen (Kwikpen). The dosage will be determined by the physician, according to the requirement of the patient.

    Arm title
    		 CSII
    Arm description
    		 Continuous subcutaneous insulin infusion (Insulin regimen)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Aspart
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For participants randomised to CSII, insulin aspart will be the insulin used. Formulation: 10 ml vial 100 Units/mL. Dosing is individual and determined in accordance with the needs of the patient. Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    For patients who have had a previous negative experience or adverse effect with Insulin Aspart the alternative of Insulin Lispro will be offered. Insulin lispro for use in the CSII group will be provided in 10ml vials 100 Units/mL.

    Arm title
    		 SMBG
    Arm description
    		 Self-monitoring of blood glucose
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Real Time
    Arm description
    		 Real Time Monitoring
    Arm type
    		 Real Time Monitoring

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Multiple daily injections CSII SMBG Real Time
    Started
    50
    46
    48
    48
    Completed
    44
    41
    40
    45
    Not completed
    6
    5
    8
    3
         Discontinued intervention - glargine intolerance
    1
    -
    -
    1
         Did not receive intervention - too busy
    -
    2
    -
    1
         Lost to follow-up
    3
    2
    4
    1
         disappointed with randomisation/too busy
    2
    -
    3
    -
         Discontinued - anxiety related to intervention
    -
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Multiple daily injections
    Reporting group description
    		 Multiple daily injections (Insulin group)

    Reporting group title
    CSII
    Reporting group description
    		 Continuous subcutaneous insulin infusion (Insulin regimen)

    Reporting group title
    SMBG
    Reporting group description
    		 Self-monitoring of blood glucose

    Reporting group title
    Real Time
    Reporting group description
    		 Real Time Monitoring

    Reporting group values
    		 Multiple daily injections CSII SMBG Real Time Total
    Number of subjects
    		 50 46 48 48 96
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 47 41 45 43 88
        From 65-84 years
    		 3 5 3 5 8
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ± 12.3 50.3 ± 12 47.1 ± 11.8 50.1 ± 12.6 -
    Gender categorical
    Units: Subjects
        Female
    		 34 27 28 33 61
        Male
    		 16 19 20 15 35
    HbA1c
    Units: Subjects
        <8%
    		 22 19 21 20 41
        ≥8%
    		 28 27 27 28 55

    End points

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    End points reporting groups
    Reporting group title
    Multiple daily injections
    Reporting group description
    		 Multiple daily injections (Insulin group)

    Reporting group title
    CSII
    Reporting group description
    		 Continuous subcutaneous insulin infusion (Insulin regimen)

    Reporting group title
    SMBG
    Reporting group description
    		 Self-monitoring of blood glucose

    Reporting group title
    Real Time
    Reporting group description
    		 Real Time Monitoring
    Reporting group title
    Multiple daily injections
    Reporting group description
    		 Multiple daily injections (Insulin group)

    Reporting group title
    CSII
    Reporting group description
    		 Continuous subcutaneous insulin infusion (Insulin regimen)

    Reporting group title
    SMBG
    Reporting group description
    		 Self-monitoring of blood glucose

    Reporting group title
    Real Time
    Reporting group description
    		 Real Time Monitoring

    Primary: Gold Score

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    End point title
    		 Gold Score
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Multiple daily injections CSII SMBG Real Time
    Number of subjects analysed
    45
    40
    42
    43
    Units: Scale score
        arithmetic mean (standard deviation)
    4.1 ± 1.6
    4.2 ± 1.7
    4.3 ± 1.6
    4 ± 1.7
    Statistical analysis title
    		 Gold Score
    Comparison groups
    Multiple daily injections v CSII
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.76
    Method
    		 t-test, 2-sided
    Parameter type
    		 Group means reported elsewhere
    Confidence interval
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Gold Score
    Comparison groups
    SMBG v Real Time
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.42
    Method
    		 t-test, 2-sided
    Parameter type
    		 Group means reported elsewhere
    Confidence interval
    Variability estimate
    Standard error of the mean

    Secondary: Clarke Score

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    End point title
    		 Clarke Score
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Multiple daily injections CSII SMBG Real Time
    Number of subjects analysed
    41
    39
    39
    41
    Units: Scale Score
        arithmetic mean (standard deviation)
    3.3 ± 1.8
    3 ± 1.6
    3.3 ± 1.6
    3.1 ± 1.8
    Statistical analysis title
    		 Clarke Score
    Statistical analysis description
    Insulin comparison at 24-week end point
    Comparison groups
    Multiple daily injections v CSII
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.31 [1]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Group means reported elsewhere
    Confidence interval
    Variability estimate
    Standard deviation
    Notes
    [1] - a priori threshold 0.05
    Statistical analysis title
    		 Clarke Score
    Comparison groups
    SMBG v Real Time
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.83 [2]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Group means reported elsewhere
    Confidence interval
    Variability estimate
    Standard deviation
    Notes
    [2] - a priori threshold 0.05

    Secondary: HypoAQ

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    End point title
    		 HypoAQ
    End point description
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Multiple daily injections CSII SMBG Real Time
    Number of subjects analysed
    44
    40
    40
    44
    Units: Scale score
        arithmetic mean (standard deviation)
    8.9 ± 4.3
    9.4 ± 4.2
    9.2 ± 4.1
    9 ± 4.4
    Statistical analysis title
    		 HypoA-Q
    Statistical analysis description
    Hypoglycaemia awareness at 24 weeks
    Comparison groups
    Multiple daily injections v CSII
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6 [3]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Group means reported elsewhere
    Confidence interval
    Variability estimate
    Standard deviation
    Notes
    [3] - a priori threshold 0.05
    Statistical analysis title
    		 HypoA-Q
    Statistical analysis description
    Hypoglycaemia awareness at 24 weeks
    Comparison groups
    SMBG v Real Time
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.83 [4]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Group means reported elsewhere
    Confidence interval
    Variability estimate
    Standard deviation
    Notes
    [4] - a priori threshold 0.05

    Secondary: SH - annualised rate

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    End point title
    		 SH - annualised rate
    End point description
    No. of severe hypos per patient year
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Multiple daily injections CSII SMBG Real Time
    Number of subjects analysed
    47
    43
    44
    46
    Units: Patient year
        arithmetic mean (standard deviation)
    1 ± 2.1
    0.6 ± 1.7
    0.9 ± 2.1
    0.8 ± 1.8
    Statistical analysis title
    		 Severe Hypos
    Statistical analysis description
    Annualised rate
    Comparison groups
    Multiple daily injections v CSII
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.34 [5]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Group means reported elsewhere
    Confidence interval
    Variability estimate
    Standard deviation
    Notes
    [5] - a priori threshold 0.05
    Statistical analysis title
    		 Severe Hypos
    Statistical analysis description
    Annualised rate
    Comparison groups
    SMBG v Real Time
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.95 [6]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Group means reported elsewhere
    Confidence interval
    Variability estimate
    Standard deviation
    Notes
    [6] - a priori threshold 0.05

    Secondary: SH - number affected

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    End point title
    		 SH - number affected
    End point description
    Severe hypos number affected
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Multiple daily injections CSII SMBG Real Time
    Number of subjects analysed
    47
    43
    44
    46
    Units: Number of individuals affected by SH
    11
    7
    9
    9
    Statistical analysis title
    		 SH number affected
    Comparison groups
    Multiple daily injections v CSII
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.399
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 SH number affected
    Comparison groups
    SMBG v Real Time
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.92
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period during which adverse events were reported from the beginning of the RCT to the end of the randomised control trial period at 24 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 As reported verbatim
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    Multiple daily injections (MDI)
    Reporting group description
    		 Multiple daily injections

    Reporting group title
    CSII
    Reporting group description
    		 Continuous subcutaneous insulin infusion

    Serious adverse events
    		 Multiple daily injections (MDI) CSII
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 50 (12.00%)
    11 / 46 (23.91%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Raised eye pressure
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastroenteritis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot ulceration
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 46 (8.70%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fracture of tibia and fibula
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture of radius
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Septic arthritis in shoulder joint
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Multiple daily injections (MDI) CSII
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 50 (28.00%)
    11 / 46 (23.91%)
    Injury, poisoning and procedural complications
    Fall
    Additional description: Slipped in garden and fell, swollen left ankle, bruising to right arm and painful ribs on right side.
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Low blood pressure
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    Mini stroke
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Meralgia paraesthetica
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Carpal tunnel decompression
    Additional description: left side
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Inflammation at injection site
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Bleeding at injection site
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Bruising at IPRO/sensor site
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 46 (2.17%)
         occurrences all number
    2
    1
    Finger cellulitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    Small raised red area after sensor is removed
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    Blister and ulceration of right toe
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Viral gastrointestinal infection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Mouth ulcer
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    Ulceration
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypoglycaemia resulting in fall
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 46 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Infections and infestations
    Viral infection
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    1
    Infected toe
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Chest infection
         subjects affected / exposed
    2 / 50 (4.00%)
    2 / 46 (4.35%)
         occurrences all number
    2
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Shingles
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Product issues
    Veo pump screen froze
    Additional description: New pump required
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Apr 2010
    Change of Principal Investigator at the Bournemouth site from Dr David Kerr to Dr Joseph Begley
    08 Jul 2010
    Clarification of details for reporting of adverse events and minor changes to the statistical analysis plan in the protocol.
    21 Dec 2011
    Addition of qualitative interview sub study for some hypoCompass study participants at the end of the RCT period.
    30 Jul 2013
    Change of Principal Investigator at the Bournemouth site from Dr Joseph Begley (now retired) to Professor David Kerr.

    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
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