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    Clinical Trial Results:
    A single-centre, open-label, randomized controlled trial of efficacy, safety and usability of a basal insulin algorithm incorporated in the GlucoTab system compared to standard care for glycaemic management in geriatric patients with type 2 diabetes at acute geriatric care wards

    Summary
    EudraCT number
    		 2017-000955-25
    Trial protocol
    		 AT  
    Global end of trial date
    05 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2021
    First version publication date
    27 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ClinDiab-08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 German Clinical Trials Register: DRKS00012553
    Sponsors
    Sponsor organisation name
    Geriatric Health Centres of the City of Graz, Austria
    Sponsor organisation address
    Albert Schweitzer Gasse 36, Graz, Austria, 8010
    Public contact
    Walter Schippinger, Geriatric Health Centres of the City of Graz, Austria, +43 31670601302, walter.schippinger@stadt.graz.at
    Scientific contact
    Walter Schippinger, Geriatric Health Centres of the City of Graz, Austria, +43 31670601302, walter.schippinger@stadt.graz.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
    05 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare efficacy of the basal-insulin algorithm (decision support) with computerized documentation (without decision support) incorporated in the GlucoTab system for glycaemic management in patients with type 2 diabetes at acute geriatric care wards
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice. All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jun 2017
    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: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    0
    From 65 to 84 years
    49
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 single-centre study - 1 site in Austria

    Pre-assignment
    Screening details
    		 60 patients signed the informed consent (IC). 31 patients were allocated to the intervention group (IG) and 29 patients to the control group (CG). All 31 patients in the IG received the allocated intervention. In the CG 27 patients received the allocated intervention (1 was erroneously screened, 1 withdrew the IC immedeately after randomization).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Decision support with GlucoTab - Intervention Group
    Arm description
    		 Insulin therapy with basal insulin (insulin glargine U300) was started and adjusted according to GlucoTab with incorporated new basal-insulin software algorithm. The goal of the basal-insulin algorithm was to maintain fasting blood glucose within the FBG target according to the predefined health level. After start, basal insulin was administered once daily before breakfast. Insulin dosage prescription was performed according to GlucoTab under supervision of the treating physician. The total daily dose was reduced by 2 units if any BG value was below target and by 4 units if any BG value was ≥ 20 mg/dL below target. The total daily dose was raised according to a titration table. Capillary glucose was measured three times daily before meals at least for the first 3 days of algorithm-based treatment and only once in the morning when therapy was verified to be stable. Correctional bolus insulin was administered according to BG targets in the predefined health status.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Toujeo 300 Einheiten/ml-Injektionslösung in einem Fertigpen
    Investigational medicinal product code
    ATC-Code: A10A E04
    Other name
    Toujeo, Sanofi-Aventis (insulin glargine U300)
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin dosage prescription was performed according to GlucoTab under supervision of the treating physician. The total daily dose was reduced by 2 units if any BG value was below target and by 4 units if any BG value was ≥ 20 mg/dL below target. The total daily dose was raised according to a titration table. Several ways of therapy adjustment were supported by the system. The most important aspect was the basal insulin dose titration. In addition, blood glucose values over the day were analysed and physicians were informed if the increase over the day was higher than 150 mg/dL with the suggestion to a) adjust concomitant medication (oral antidiabetic or incretin agents – “basal insulin supported oral therapy / incretin therapy”) b) add a short acting insulin once daily (“Basal plus therapy”) or c) to use a therapy other than basal insulin if a) and b) were not successful or the total daily insulin dose was above a defined threshold.

    Investigational medicinal product name
    Apidra SoloStar 100 Einheiten/ml-Injektionslösung in einem Fertigpen
    Investigational medicinal product code
    ATC-Code: A10A B06
    Other name
    Apidra, Sanofi Aventis (Insulin glulisine)
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    BG corrections with short acting insulin for very high BG values were performed according to GlucoTab suggestions. Correctional bolus insulin was administered at defined time-points according to BG targets in the predefined health status. The insulin was administered sc via insulin pen by the nurses.

    Arm title
    		 Documentation only in GlucoTab - Control Group
    Arm description
    		 Study participants in the control group received standard insulin therapy as judged by the treating physician. This therapy was documented by the health professionals using the GlucoTab system with the feature “custom therapy” without decision support. BG measurements were performed according to the treating physician. To guarantee comparability between treatment and control group at least 3 BG measurements a day for the first three days and later at least FBG values had to be measured.
    Arm type
    		 as judged by the treating physician

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Started
    31
    27
    Completed
    28
    27
    Not completed
    3
    0
         Physician decision
    1
    -
         Patient decision
    1
    -
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Decision support with GlucoTab - Intervention Group
    Reporting group description
    		 Insulin therapy with basal insulin (insulin glargine U300) was started and adjusted according to GlucoTab with incorporated new basal-insulin software algorithm. The goal of the basal-insulin algorithm was to maintain fasting blood glucose within the FBG target according to the predefined health level. After start, basal insulin was administered once daily before breakfast. Insulin dosage prescription was performed according to GlucoTab under supervision of the treating physician. The total daily dose was reduced by 2 units if any BG value was below target and by 4 units if any BG value was ≥ 20 mg/dL below target. The total daily dose was raised according to a titration table. Capillary glucose was measured three times daily before meals at least for the first 3 days of algorithm-based treatment and only once in the morning when therapy was verified to be stable. Correctional bolus insulin was administered according to BG targets in the predefined health status.

    Reporting group title
    Documentation only in GlucoTab - Control Group
    Reporting group description
    		 Study participants in the control group received standard insulin therapy as judged by the treating physician. This therapy was documented by the health professionals using the GlucoTab system with the feature “custom therapy” without decision support. BG measurements were performed according to the treating physician. To guarantee comparability between treatment and control group at least 3 BG measurements a day for the first three days and later at least FBG values had to be measured.

    Reporting group values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group Total
    Number of subjects
    		 31 27 58
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 25 24 49
        85 years and over
    		 6 3 9
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 78 ± 6 76 ± 6 -
    Gender categorical
    Units: Subjects
        Female
    		 20 17 37
        Male
    		 11 10 21
    Individual health status
    Units: Subjects
        tight
    		 8 7 15
        moderate
    		 23 20 43
        loose
    		 0 0 0
    HbA1c at study start
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 61 ± 21 64 ± 13 -

    End points

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    End points reporting groups
    Reporting group title
    Decision support with GlucoTab - Intervention Group
    Reporting group description
    		 Insulin therapy with basal insulin (insulin glargine U300) was started and adjusted according to GlucoTab with incorporated new basal-insulin software algorithm. The goal of the basal-insulin algorithm was to maintain fasting blood glucose within the FBG target according to the predefined health level. After start, basal insulin was administered once daily before breakfast. Insulin dosage prescription was performed according to GlucoTab under supervision of the treating physician. The total daily dose was reduced by 2 units if any BG value was below target and by 4 units if any BG value was ≥ 20 mg/dL below target. The total daily dose was raised according to a titration table. Capillary glucose was measured three times daily before meals at least for the first 3 days of algorithm-based treatment and only once in the morning when therapy was verified to be stable. Correctional bolus insulin was administered according to BG targets in the predefined health status.

    Reporting group title
    Documentation only in GlucoTab - Control Group
    Reporting group description
    		 Study participants in the control group received standard insulin therapy as judged by the treating physician. This therapy was documented by the health professionals using the GlucoTab system with the feature “custom therapy” without decision support. BG measurements were performed according to the treating physician. To guarantee comparability between treatment and control group at least 3 BG measurements a day for the first three days and later at least FBG values had to be measured.

    Primary: The percentage of fasting blood glucose (FBG) values in the FBG target range as calculated by using all FBG values measured ≥ 24 hours after start of therapy

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    End point title
    		 The percentage of fasting blood glucose (FBG) values in the FBG target range as calculated by using all FBG values measured ≥ 24 hours after start of therapy
    End point description
    The percentage of fasting blood glucose (FBG) values in the FBG target range as calculated by using all FBG values measured ≥ 24 hours after start of therapy. The target range depended on the health status of a subject and was defined as follows: - Tight glycaemic control: 90–130 mg/dL - Moderate glycaemic control: 90–150 mg/dL
    End point type
    Primary
    End point timeframe
    whole study duration starting >= 24 h after start of therapy
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: Percentage
        arithmetic mean (standard deviation)
    58.6 ± 33.2
    51.2 ± 30.8
    Statistical analysis title
    		 efficacy of the basal-insulin algorithm
    Statistical analysis description
    Null Hypothesis (H0): Intervention group (basal insulin algorithm) and control group (computerized documentation without decision support) do not differ with respect to the percentage of fasting blood glucose (FBG) values in the FBG target range (as calculated by using all FBG values measured ≥ 24 hours after start of therapy).
    Comparison groups
    Decision support with GlucoTab - Intervention Group v Documentation only in GlucoTab - Control Group
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 bootstrapping
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.938
         upper limit
    		 24.534
    Notes
    [1] - bootstrapping and confidence interval as result
    [2] - The primary endpoint of the study deviates from normality, thus the Intervention Group and Control Group were compared by means of a data-based simulation method (bootstrap method described in the SAP).

    Secondary: Overall mean FBG value (pre-breakfast BG)

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    End point title
    		 Overall mean FBG value (pre-breakfast BG)
    End point description
    overall FBG value (pre-breakfast BG)
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: mg/dl
        arithmetic mean (standard deviation)
    142 ± 49
    150 ± 38
    No statistical analyses for this end point

    Secondary: Mean daily BG

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    End point title
    		 Mean daily BG
    End point description
    The mean daily BG was calculated for the first three treatment days only, as there were only three daily measurements on these days.
    End point type
    Secondary
    End point timeframe
    first three treatment days
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: mg/dl
        arithmetic mean (standard deviation)
    195 ± 74
    201 ± 46
    No statistical analyses for this end point

    Secondary: Percentage of BGs below, within or above health dependent target range

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    End point title
    		 Percentage of BGs below, within or above health dependent target range
    End point description
    health dependent target range for tight: 90-130 mg/dl; moderate: 90-150 mg/dl; loose: 100-180 mg/dl
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: Percentage
    number (not applicable)
        BGs below health dependent target range
    3.5
    0.6
        BGs within health dependent target range
    74.8
    74.8
        BGs above health dependent target range
    21.7
    24.6
    No statistical analyses for this end point

    Secondary: Percentage of administered insulin therapy types and concomitant diabetes medication according to treatment days

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    End point title
    		 Percentage of administered insulin therapy types and concomitant diabetes medication according to treatment days
    End point description
    Total number of treatment days in IG were 428, total number of treatment days in control group were 432
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: Percentage
    number (not applicable)
        Basal insulin
    74.1
    72.2
        Basal insulin plus 1 short acting insulin
    15.2
    21.3
        Long acting insulin plus > 1 short acting insulin
    10.3
    1.9
        Premixed insulin
    0
    4.4
        Short acting insulin only
    0.5
    0.2
        Concomitant OAD
    79.2
    77.1
        Concomitant GLP-1
    0
    5.1
    No statistical analyses for this end point

    Secondary: Percentage of days with BG values below the individual glycaemic target range

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    End point title
    		 Percentage of days with BG values below the individual glycaemic target range
    End point description
    FBG target ranges for tight: 90-130 mg/dl; moderate: 90-150 mg/dl; loose: 100-180 mg/dl
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: Percentage
    number (not applicable)
        days with pre-breakfast BGs below target
    5.3
    0.4
        days with pre-lunch BG below target
    1.8
    0.9
        days with pre-dinner BG below target
    0.7
    0
    No statistical analyses for this end point

    Secondary: Number of BG measurements per treatment day

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    End point title
    		 Number of BG measurements per treatment day
    End point description
    number of BG measurements per treatment day based on mean values for each subject
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: number of BG measurements/day
        arithmetic mean (standard deviation)
    2.4 ± 0.5
    2.4 ± 0.4
    No statistical analyses for this end point

    Secondary: Initial insulin dose and insulin end dose

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    End point title
    		 Initial insulin dose and insulin end dose
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: units (IU)
    arithmetic mean (standard deviation)
        initial insulin dose
    17 ± 7
    17 ± 6
        insulin end dose
    17 ± 11
    19 ± 8
        initial basal insulin dose
    15 ± 5
    16 ± 5
        basal insulin end dose
    15 ± 8
    18 ± 7
    No statistical analyses for this end point

    Secondary: Percentage of adherence to GlucoTab suggestions (IG only)

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    End point title
    		 Percentage of adherence to GlucoTab suggestions (IG only)
    End point description
    this endpoint is for IG only since there is no decision support for CG
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: Percentage
    number (not applicable)
        days with compliant BG measurement frequency
    88.8
    0
        adherence to insulin start dose suggestions
    44.4
    0
        adherence to suggested basal ins. titration dose
    82
    0
        adherence to suggested basal ins. injection dose
    89.5
    0
        adherence to suggested bolus ins. injection dose
    65.7
    0
    No statistical analyses for this end point

    Secondary: Subgroup tight glycaemic control: Percentage of BG values in specific ranges according to health dependent target ranges

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    End point title
    		 Subgroup tight glycaemic control: Percentage of BG values in specific ranges according to health dependent target ranges
    End point description
    Percentage of BG values in specific ranges according to health dependent target ranges for tight glycaemic control
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    8
    7
    Units: Percentage of BGs
    number (not applicable)
        0-39 mg/dl
    0
    0
        40-69 mg/dl
    0
    0.3
        70-89 mg/dl
    4.4
    0
        90-130 mg/dl
    41.9
    22.7
        131-260 mg/dl
    51.5
    66.1
        261-349 mg/dl
    2.2
    8.8
        > 349 mg/dl
    0
    2
    No statistical analyses for this end point

    Secondary: Subgroup moderate glycaemic control: Percentage of BG values in specific ranges according to health dependent target ranges

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    End point title
    		 Subgroup moderate glycaemic control: Percentage of BG values in specific ranges according to health dependent target ranges
    End point description
    Percentage of BG values in specific ranges according to health dependent target ranges for moderate glycaemic control
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    23
    20
    Units: Percentage
    number (not applicable)
        0-39 mg/dl
    0
    0
        40-69 mg/dl
    0.4
    0.1
        70-89 mg/dl
    2.9
    0.5
        90-150 mg/dl
    34.4
    38.7
        151-300 mg/dl
    52.9
    57.3
        301-349 mg/dl
    4.1
    2.3
        > 349 mg/dl
    5.3
    1.1
    No statistical analyses for this end point

    Secondary: Number of performed, suggested, missed and additional daily BG measurements

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    End point title
    		 Number of performed, suggested, missed and additional daily BG measurements
    End point description
    Number of performed, suggested, missed and additional daily BG measurements per group based on values for each subject and treatment day
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: number of BG measurements
    arithmetic mean (standard deviation)
        Number of performed daily BG measurements
    2.5 ± 1.0
    2.4 ± 0.9
        Number of suggested daily BG measurements
    2.1 ± 1.0
    2.4 ± 0.9
        Number of missed daily BG measurements
    0.2 ± 0.5
    0.3 ± 0.6
        Number of additional daily BG measurements
    0.5 ± 0.8
    0.3 ± 0.6
    No statistical analyses for this end point

    Secondary: Initial insulin dose and insulin end dose relative to subject weight

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    End point title
    		 Initial insulin dose and insulin end dose relative to subject weight
    End point description
    mean initial insulin dose and mean insulin end dose relative to subject weight
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: IU/kg
    arithmetic mean (standard deviation)
        initial insulin dose (IU/kg)
    0.21 ± 0.08
    0.21 ± 0.06
        insulin end dose (IU/kg)
    0.22 ± 0.14
    0.23 ± 0.08
        initial basal insulin dose (IU/kg)
    0.19 ± 0.06
    0.19 ± 0.05
        basal insulin end dose(IU/kg)
    0.20 ± 0.10
    0.23 ± 0.07
    No statistical analyses for this end point

    Secondary: Mean number of daily insulin injections

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    End point title
    		 Mean number of daily insulin injections
    End point description
    mean number of daily insulin injections per group. A total of 599 (IG) vs. 541 (CG) insulin injections were performed.
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: mean number of insulin injections
    arithmetic mean (standard deviation)
        number of performed insulin injections
    1.40 ± 0.77
    1.25 ± 0.48
        number of insulin injections suggested by GlucoTab
    1.22 ± 0.71
    1.23 ± 0.54
        number of non-performed insulin injections
    0.01 ± 0.11
    0.02 ± 0.18
        number of additional insulin injections
    0.18 ± 0.46
    0.04 ± 0.22
    No statistical analyses for this end point

    Secondary: Number of falls

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    End point title
    		 Number of falls
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Number of subjects analysed
    31
    27
    Units: number
    3
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed during the whole study duration; Time range: 14.06.2017 (FPFV) - 05.10.2018 (LPLV)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Decision support with GlucoTab - Intervention Group
    Reporting group description
    		 Insulin therapy with basal insulin (insulin glargine U300) was started and adjusted according to GlucoTab with incorporated new basal-insulin software algorithm. The goal of the basal-insulin algorithm was to maintain fasting blood glucose within the FBG target according to the predefined health level. After start, basal insulin was administered once daily before breakfast. Insulin dosage prescription was performed according to GlucoTab under supervision of the treating physician. The total daily dose was reduced by 2 units if any BG value was below target and by 4 units if any BG value was ≥ 20 mg/dL below target. The total daily dose was raised according to a titration table. Capillary glucose was measured three times daily before meals at least for the first 3 days of algorithm-based treatment and only once in the morning when therapy was verified to be stable. Correctional bolus insulin was administered according to BG targets in the predefined health status.

    Reporting group title
    Documentation only in GlucoTab - Control Group
    Reporting group description
    		 Study participants in the control group received standard insulin therapy as judged by the treating physician. This therapy was documented by the health professionals using the GlucoTab system with the feature “custom therapy” without decision support.

    Serious adverse events
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 27 (7.41%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Musculoskeletal and connective tissue disorders
    Fall causing contusio capitis and contusio occygis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall causing Fracture Massa lat. sin.
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall causing fract. subcap. hum. dext.
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Encephalitis, NINS
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Decision support with GlucoTab - Intervention Group Documentation only in GlucoTab - Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 31 (32.26%)
    12 / 27 (44.44%)
    Cardiac disorders
    Cardiac decompensation
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Collapse
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
    Additional description: Nausea under opiate therapy
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Clostridia enteritis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
    Additional description: respiratory tract infection of the upper respiratory tract
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Detoriation of the liver parenchyma
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatomycosis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    2 / 31 (6.45%)
    3 / 27 (11.11%)
         occurrences all number
    2
    3
    Endocrine disorders
    Hypoglycaemia
    Additional description: hypoglycaemia without symptoms
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Fall
         subjects affected / exposed
    2 / 31 (6.45%)
    4 / 27 (14.81%)
         occurrences all number
    2
    4
    Gout arthritis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1

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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.
    similarity of both groups was not taken into account in the power calculation; less patients than calculated in the sample size calculation were included in the study; no patients with health status "loose" glycaemic control were included;
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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