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    Summary
    EudraCT Number:2018-000863-98
    Sponsor's Protocol Code Number:GlucoTab@MobileCare
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2018-000863-98
    A.3Full title of the trial
    A single-centre, open-label, non-controlled trial of acceptance, usability, safety and efficacy of a tablet based workflow and decision support system with incorporated basal-insulin algorithm for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care
    Offene, monozentrische, nicht kontrollierte Studie zur Untersuchung der Akzeptanz, Benutzerfreundlichkeit, Sicherheit und Wirksamkeit eines Tablet basierten Arbeitsablauf- und Entscheidungsunterstützungssystems mit integriertem Basalinsulin Algorithmus zum Blutzuckermanagement bei PatientInnen mit Typ 2 Diabetes in der mobilen Hauskrankenpflege
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of acceptance, usability, safety and efficacy of the GlucoTab@MobileCare system for type 2 diabetes in domiciliary nursing care
    Überprüfung der Akzeptanz, Benutzerfreundlichkeit, Sicherheit und Wirksamkeit des GlucoTab@MobileCare Systems für Typ 2 Diabetes in der mobilen Hauskrankenpflege
    A.3.2Name or abbreviated title of the trial where available
    GlucoTab@MobileCare basal-insulin algorithm in domiciliary nursing care
    GlucoTab@MobileCare Basalinsulin Algorithmus in der mobilen Hauskrankenpflege
    A.4.1Sponsor's protocol code numberGlucoTab@MobileCare
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical University of Graz
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZukunftfonds Steiermark
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Graz
    B.5.2Functional name of contact pointSponsor contact
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 15
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8010
    B.5.3.4CountryAustria
    B.5.4Telephone number00430316385-72766
    B.5.6E-mailangela.libiseller@medunigraz.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Toujeo
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.4EV Substance CodeSUB08196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Apidra
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInsulin Glulisine
    D.3.9.1CAS number 207748-29-6
    D.3.9.3Other descriptive nameINSULIN GLULISINE
    D.3.9.4EV Substance CodeSUB20054
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetes mellitus type 2
    Diabetes mellitus Typ 2
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes
    Typ 2 Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the acceptance of the GlucoTab@MobileCare system for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care
    E.2.2Secondary objectives of the trial
    To investigate usability, safety and efficacy parameters of the basal-insulin algorithm incorporated in the GlucoTab@MobileCare system for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Informed consent obtained after being advised of the nature of the study
    Male or female aged ≥ 18 years
    Type 2 diabetes (treated with insulin therapy)
    Receiving domiciliary nursing care by the OERK Graz
    E.4Principal exclusion criteria
    • Type 1 diabetes
    • Instable corticosteroid therapy
    • Any disease or condition which the investigator feels would interfere with the trial or the safety of the patient
    • Any mental condition rendering the patient incapable of giving his/her consent
    • intravenous insulin therapy
    • hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
    • Gestational diabetes or pregnancy
    • Known or suspected allergy to certain insulin types
    • Terminally ill patients
    • total parenteral nutrition (TPN)
    • Participation in another trial which could influence the basal-insulin algorithm
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of actions the system supports either to capture BG values or provide insulin dose suggestions according to the basal insulin algorithm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Length of GlucoTab@MobileCare treatment
    E.5.2Secondary end point(s)
    • Number of BG values below individual glycaemic target range according to health status (plus time of day)
    • Number of blood glucose measurements per day
    • Insulin dose (Total daily dose (TDD), basal insulin dose, bolus insulin dose)
    • Number of insulin injections per day
    • Number of non-performed insulin injections per day
    • Type of start (according to algorithm OR as judged by physician)
    • Number of adverse events, device-related adverse events and serious adverse events
    • Differences between BG values entered in GlucoTab@MobileCare and BG values recorded by AccuChek® Guide


    • User satisfaction with the GlucoTab@MobileCare system regarding the user interface and the provided functionality
    • Other usability parameters like user workload and support of treatment workflow
    • Physician adherence to insulin starting dose suggestion (according to algorithm OR as judged by physician)
    • Nurse adherence to suggested basal-insulin adjustment/titration dose
    • Nurse adherence to suggested basal-insulin injection dose
    • Nurse adherence to suggested timing of adjustment/titration
    • Number of missed blood glucose measurements per day
    • Number of additionally performed blood glucose measurements per day
    • Adherence to suggested BG measurement frequency
    • Nurse adherence to suggested short-acting insulin injection dose
    • Patient/relative usability/practicability parameters as assessed by questionnaire at the end of trial
    • Nurse usability/practicability parameters as assessed by questionnaire before start and at the end of trial

    • Mean percentage of FBGs in the FBG target range according to health status calculated by all FBGs measured ≥ 24 hours after start of therapy
    • Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean daily pre-meal blood glucose (calculated if at least 3 pre-meal BG values per day available): overall and per treatment day
    • Number and percentage of values of the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<90 mg/dl, 90-<100 mg/dl, 90-260 mg/dl, 90-300 mg/dl, 100-350 mg/dl, >261-<300 mg/dl, 300-<350 mg/dl, ≥ 350 mg/dl
    • Insulin starting dose
    • Final insulin dose
    • Number and percentage of FBGs < FBG target or > FBG target
    • Days with FBGs in target (according to health status)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Length of GlucoTab@MobileCare treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-05-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the study information regarding diabetes therapy for the primary health care provider will be obtained. The study patients will continue the basal-insulin therapy unless a therapy change is indicated by the investigator or the treating physician. No follow-up visit is included in the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-30
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