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    Clinical Trial Results:
    An open, single-centre, non-controlled study of efficacy, safety and usability of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards

    Summary
    EudraCT number
    		 2013-001295-38
    Trial protocol
    		 AT  
    Global end of trial date
    23 Dec 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    ClinDiab-04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01932775
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz, Univ. Prof. Dr. Thomas Pieber, Department of Internal Medicine, Division of Endocrinology and Diabetology
    Sponsor organisation address
    Auenbruggerplatz 15, Graz, Austria, 8036
    Public contact
    Subinvestigator, Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology, +43 31638512383, julia.mader@medunigraz.at
    Scientific contact
    Subinvestigator, Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology, +43 31638512383, julia.mader@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
    26 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at different general 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
    16 May 2013
    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: 99
    Worldwide total number of subjects
    99
    EEA total number of subjects
    99
    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)
    38
    From 65 to 84 years
    57
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Single-centre study - 1 site in Austria - 99 subjects Recruitment started on 16-May-2013. Patients with type 2 diabetes mellitus or newly diagnosed hyperglycaemia treated initially with oral agents, non-insulin injected antidiabetic medicine, insulin, diet or any combination of the four, and who were hospitalised at the Medical University of Graz.

    Pre-assignment
    Screening details
    		 100 patients have been screened and in total 99 patients were included. 97 patients completed the study according to study protocol and two patients were withdrawn. A physician explained the nature, purpose and risks of the study and provided the patient with a copy of the patient information sheet.

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

    Arms
    Arm title
    		 ClinDiab04
    Arm description
    		 Glinide, Sulfonylureas and Glitazones were stopped. Metformin, GLP-1 Analoga and DPP-4 inhibitors were continued according local standard procedures. Insulin therapy was adjusted according to the GlucoTab® system with incorporated software algorithm. As judged by the investigator, a glucose sensor (iPro2) was inserted subcutaneously to monitor glucose continuously to gain more detailed information about the algorithm for further improvement. Insulin regimen and insulin dosage prescription for the next 24 hours was performed once daily according to the GlucoTab® system under supervision of the treating physician. Capillary glucose was measured before meals and at bedtime. If a patient was not eating, insulin glargine was given but insulin Novorapid was held. Correctional insulin was given according to glucose levels.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lantus Solostar 100 Einheiten/ml Injektionslösung in einem Fertigpen
    Investigational medicinal product code
    ATC-Code: A10A E04
    Other name
    Insulin glargin
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin regimen and insulin dosage prescription for the next 24 hours was performed once daily according to the GlucoTab® system under supervision of the treating physician. The goal of the insulin protocol was to maintain fasting and pre-meal glucose concentrations between 70 and 140 mg/dl. Insulin was started at a total daily dose of 0.5 units/kg divided half as insulin glargine once daily and the other half as insulin Novorapid given before meals.

    Investigational medicinal product name
    Novorapid Flexpen
    Investigational medicinal product code
    ATC-Code: A10A B05
    Other name
    insulin aspart
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin regimen and insulin dosage prescription for the next 24 hours was performed once daily according to the GlucoTab® system under supervision of the treating physician. The goal of the insulin protocol was to maintain fasting and pre-meal glucose concentrations between 70 and 140 mg/dl. Insulin was started at a total daily dose of 0.5 units/kg divided half as insulin glargine once daily and the other half as insulin Novorapid given before meals.

    Number of subjects in period 1
    		ClinDiab04
    Started
    99
    Completed
    99

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ClinDiab04
    Reporting group description
    		 Glinide, Sulfonylureas and Glitazones were stopped. Metformin, GLP-1 Analoga and DPP-4 inhibitors were continued according local standard procedures. Insulin therapy was adjusted according to the GlucoTab® system with incorporated software algorithm. As judged by the investigator, a glucose sensor (iPro2) was inserted subcutaneously to monitor glucose continuously to gain more detailed information about the algorithm for further improvement. Insulin regimen and insulin dosage prescription for the next 24 hours was performed once daily according to the GlucoTab® system under supervision of the treating physician. Capillary glucose was measured before meals and at bedtime. If a patient was not eating, insulin glargine was given but insulin Novorapid was held. Correctional insulin was given according to glucose levels.

    Reporting group values
    		 ClinDiab04 Total
    Number of subjects
    		 99 99
    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)
    		 38 38
        From 65-84 years
    		 57 57
        85 years and over
    		 4 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.2 ± 10.6 -
    Gender categorical
    Units: Subjects
        Female
    		 41 41
        Male
    		 58 58
    HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 65.1 ± 21.3 -
    Serum creatinine
    Units: mg/dl
        arithmetic mean (standard deviation)
    		 1.8 ± 1.5 -

    End points

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    End points reporting groups
    Reporting group title
    ClinDiab04
    Reporting group description
    		 Glinide, Sulfonylureas and Glitazones were stopped. Metformin, GLP-1 Analoga and DPP-4 inhibitors were continued according local standard procedures. Insulin therapy was adjusted according to the GlucoTab® system with incorporated software algorithm. As judged by the investigator, a glucose sensor (iPro2) was inserted subcutaneously to monitor glucose continuously to gain more detailed information about the algorithm for further improvement. Insulin regimen and insulin dosage prescription for the next 24 hours was performed once daily according to the GlucoTab® system under supervision of the treating physician. Capillary glucose was measured before meals and at bedtime. If a patient was not eating, insulin glargine was given but insulin Novorapid was held. Correctional insulin was given according to glucose levels.

    Primary: Mean percentage of blood glucose values in the target range 70-140 mg/dl

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    End point title
    		 Mean percentage of blood glucose values in the target range 70-140 mg/dl [1]
    End point description
    In a recent clinical trial the percentage of BG measurements within the target range between 70 and 140 mg/dl was 42%, using a basal-bolus algorithm (Umpierrez, Smiley, et al., 2013). The primary endpoint of this study was the verification of efficacy of the GlucoTab® system for blood glucose management by demonstrating at least the same performance regarding BG measurements in the target range.
    End point type
    Primary
    End point timeframe
    whole study duration
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: All parameters were analysed by descriptive and explorative statistical methods. No hypotheses were tested. The primary endpoint was "the percentage of actions the GlucoTab system supports either to capture BG values or provide insulin dose suggestions according to the REACTION algorithm"
    End point values
    		 ClinDiab04
    Number of subjects analysed
    99
    Units: Percentage
        arithmetic mean (standard deviation)
    50.2 ± 22.2
    No statistical analyses for this end point

    Secondary: Blood glucose measurements in different ranges

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    End point title
    		 Blood glucose measurements in different ranges
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 ClinDiab04
    Number of subjects analysed
    99
    Units: Percentage
    number (not applicable)
        0-<40 mg/dl
    0
        40-<60 mg/dl
    0.5
        40-<70 mg/dl
    1.8
        70-<100 mg/dl
    14.3
        100-140 mg/dl
    33
        >140-<180 mg/dl
    25.2
        180-<300 mg/dl
    23
        >=300 mg/dl
    2.7
    No statistical analyses for this end point

    Secondary: Mean daily blood glucose

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    End point title
    		 Mean daily blood glucose
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 ClinDiab04
    Number of subjects analysed
    99
    Units: mg/dl
        arithmetic mean (standard deviation)
    154 ± 34.5
    No statistical analyses for this end point

    Secondary: Missed BG measurements and insulin injections

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    End point title
    		 Missed BG measurements and insulin injections
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration except first and last study day
    End point values
    		 ClinDiab04
    Number of subjects analysed
    99
    Units: Percentage
    number (not applicable)
        missed blood glucose measurements
    4.2
        missed bolus insulin injections
    5.3
        missed basal insulin injections
    1.4
    No statistical analyses for this end point

    Secondary: Number of BG measurements per day, standard bolus insulin injections, standard basal insulin injections

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    End point title
    		 Number of BG measurements per day, standard bolus insulin injections, standard basal insulin injections
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 ClinDiab04
    Number of subjects analysed
    99
    Units: number
    number (not applicable)
        number of BG measurements per day
    3.8
        standard bolus insulin injections
    3.1
        standard basal insulin injections
    1.0
    No statistical analyses for this end point

    Secondary: Insulin dose corrections

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    End point title
    		 Insulin dose corrections
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 ClinDiab04
    Number of subjects analysed
    99
    Units: IU
    arithmetic mean (standard deviation)
        bolus insulin correction
    -0.5 ± 1.6
        basal insulin correction
    -0.6 ± 2.9
    No statistical analyses for this end point

    Secondary: Insulin corrections by the user (%)

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    End point title
    		 Insulin corrections by the user (%)
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration excluding day 1
    End point values
    		 ClinDiab04
    Number of subjects analysed
    99
    Units: Percentage
    number (not applicable)
        basal insulin corrections
    3.3
        bolus insulin corrections
    3.5
    No statistical analyses for this end point

    Secondary: Health care professionals' adherence to suggested insulin doses

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    End point title
    		 Health care professionals' adherence to suggested insulin doses
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration except day 1 of study
    End point values
    		 ClinDiab04
    Number of subjects analysed
    99
    Units: Percentage
    number (not applicable)
        physician adherence to basal insulin doses
    96.7
        nurse adherence to bolus insulin doses
    96.5
    No statistical analyses for this end point

    Secondary: Overall mean BG values

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    End point title
    		 Overall mean BG values
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 ClinDiab04
    Number of subjects analysed
    99
    Units: mg/dl
    arithmetic mean (standard deviation)
        overall pre-breakfast BG
    147 ± 43.2
        overall pre-lunch BG
    170 ± 54.3
        overall pre-dinner BG
    153 ± 40.8
        overall bedtime BG
    153 ± 38.5
        pre-enrolment BG
    188 ± 72.9
    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
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    ClinDiab04
    Reporting group description
    		 Glinide, Sulfonylureas and Glitazones were stopped. Metformin, GLP-1 Analoga and DPP-4 inhibitors were continued according local standard procedures. Insulin therapy was adjusted according to the GlucoTab® system with incorporated software algorithm. As judged by the investigator, a glucose sensor (iPro2) was inserted subcutaneously to monitor glucose continuously to gain more detailed information about the algorithm for further improvement. Insulin regimen and insulin dosage prescription for the next 24 hours was performed once daily according to the GlucoTab® system under supervision of the treating physician. Capillary glucose was measured before meals and at bedtime. If a patient was not eating, insulin glargine was given but insulin Novorapid was held. Correctional insulin was given according to glucose levels.

    Serious adverse events
    		 ClinDiab04
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 99 (1.01%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    In-stent thrombosis Stent Thrombosis (RCX)
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ClinDiab04
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 99 (29.29%)
    Vascular disorders
    AV-fistula right inguinal
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Myalgic headache
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Haematoma and false aneurysm of the right femoral artery after coronary angiography
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Multiple stenoses of arteries of the lower leg on both sides
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Cardiac disorders
    Stent thrombosis RCX
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Progression of coronary artery disease
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Coronary artery disease (3 vessels)
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Coronary astery disease (1 vessel)
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Epistaxis
         subjects affected / exposed
    2 / 99 (2.02%)
         occurrences all number
    2
    Hypoferremia anemia
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Gastrointestinal disorders
    Athrophic gastritis
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Gastric polyps
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Reflux esophagitis
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Mild respiratory abnormality with restrictive pattern
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Respiratory abnormality with restrictive and obstructive pattern
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Hepatobiliary disorders
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Cirrhosis of the liver
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Haematoma and swelling of the right leg
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Haematoma on the right back of the hand
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Intertrigo
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Renal and urinary disorders
    Urethritis
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Glomerulonephritis
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Shoulder osteoarthritis on both sides
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1
    Osteopenia
         subjects affected / exposed
    2 / 99 (2.02%)
         occurrences all number
    2
    Infections and infestations
    Infection with fever
         subjects affected / exposed
    1 / 99 (1.01%)
         occurrences all number
    1

    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.
    the number of included patients per ward was not equal (less patients from surgical wards); the study team supported and reminded clinical staff to perform necessary tasks of the GlucoTab
    For support, Contact us.
    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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