Trial document




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  DRKS00015119

Trial Description

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Title

Pilot study to evaluate glycemic control with GlucoTab using an ultra-long acting insulin analogue in non-critically ill patients with type 2 diabetes at the general ward

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Trial Acronym

Glucotab_Degludec

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study enrolls patients over the age of 18 with manifest type 2 diabetes mellitus, which aims to improve glycemic control by using GlucoTab, an electronic insulin dose decision support system. The GlucoTab system supports clinical staff. It automatically suggests the amount of insulin to be administered by medical staff using an insulin calculation scheme.
The goal is to reduce elevated blood sugar levels during acute illness and hospitalization.

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Brief Summary in Scientific Language

This open-label, single-center, prospective clinical Trial evaluates the possibility to monitor the glycemic control in patients over the Age of 18 with type 2 diabetes mellitus when using the GlucoTab system with Insulin Degludec (Tresiba). Patients with type 2 diabetes or newly diagnosed hyperglycemia will be included in this study.
Hyperglycaemia in hospitalized patients is one of the most common and cost intensive problems of today's healthcare and is often associated with poor disease outcome and mortality. Poor glycaemic control is also associated with prolongation in hospitalization, infections, post-discharge disabilities, and death. The current guidelines recommend a fasting blood sugar value of <140 mg / dl. Insulin, either administered intravenously or subcutaneously should be the first choice for controlling the blood glucose in hospitalized patients. An algorithm for basal-bolus therapy has been developed with the electronic decision support system GlucoTab. In this study, the feasibility of glycemic control with the ultra-long-acting insulin degludec (Tresiba) in hospitalized patients using GlucoTab is being evaluated. Insulin Degludec is thought to reduce the number of hypoglycemic events. A subcutaneous glucose sensor is placed in the subcutaneous tissue of all participants. During the hospital stay, for a maximum of 21 days, the blood sugar of the study participants is managed with GlucoTab. Parameters such as plasma glucose, subcutaneous glucose, insulin dose and concomitant medication will be collected during the ward round. Capillary blood glucose measurements will be done before meals and at bedtime. If there is no meal intake, an appropriate correction insulin dose will be administered, if necessary. The GlucoTab algorithm calculates the amount of insulin to be administered based on the blood sugar profile of the last 24 hours. The dose of insulin suggested by GlucoTab can be overruled by a physician at any time. The study ends for the participants as soon as they are discharged from the ward.

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Organizational Data

  •   DRKS00015119
  •   2019/04/29
  •   [---]*
  •   yes
  •   Approved
  •   30-491 ex 17/18, Ethikkommission der Medizinischen Universität Graz Auenbruggerplatz 2 8036 Graz Austria
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Secondary IDs

  •   2018-002646-36 
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Health Condition or Problem studied

  •   E11 -  Type 2 diabetes mellitus
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Interventions/Observational Groups

  •   Patients suffering from type 2 diabetes mellitus equal or over the age of 18 will be included in this study. After obtaining informed consent, body measurements (body weight, height and body mass index [calculated as body weight/(height)2), vital signs (diastolic and systolic blood pressure, pulse, body temperature], renal function parameters and routine laboratory parameters [HbA1c, creatinine, blood glucose] as recorded in the patient file will be documented. A urine pregnancy test in female participants of childbearing potential will also be performed. Glinide, Sulfonylureas and Glitazones will be stopped, Metformin, SGLT2-inhibitors, GLP-1 analogues and DPP-4-inhibitors will be continued and and subjects will be treated with GlucoTab and the integrated algorythm for basal bolus therapy using insulin degludec and insulin aspart. Subjects has to stay equal or longer than 48 hours on the general ward to be inculded in the study. The duration of the study is the length of the hospital stay or a maximum of 21 days after admission. Blood glucose measurements and insulin dosing is performed and documented by the nurse on duty. The suggested insulin dose can be overruled by the treating physician at any time and/or an additional glucose measurement
    At discharge patients will return to their previous antidiabetic treatment, unless a further insulin therapy is indicated by the treating physician.
    Blinded continuous subcutaneous glucose monitoring (CGM) will be performed throughout the study to better understand glycemic excursions over time.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy

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Secondary Outcome

Number of hypoglycemic episodes requiring third party help

Number of blood glucose measurements per day

Number of missed blood glucose measurements per day

Number of additionally required blood glucose measurements

Insulin dose - basal, bolus and corrective insulin dose per day

Number of insulin injections per day

Number and reasons for non-performance of insulin injections per day

Relevant concomitant medication (corticosteroids, parenteral nutrition, oral hypoglycemic agents)

Adherence to the insulin dose suggestion of the GlucoTab system

Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day

Mean pre-breakfast blood glucose, mean prelunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose

Mean pre-enrolment blood glucose

Number and percentage of the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<100 mg/dl, 100140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl.

Time of glucose measurements (CGM) in the following ranges: 40-<70 mg/dl, 70-<100 mg/dl, 100-140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/05/15
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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 diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycemia which requires s.c. insulin therapy

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Exclusion Criteria

Type 1 diabetes, gestational diabetes

Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient

continuous subcutaneous insulin infusion (CSII)

hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy

Pregnancy

Any mental condition rendering the patient incapable of giving his consent

Known or suspected allergy to insulin degludec or insulin aspart

Continuous parenteral nutrition

Participation in another trial which can influence outcome of the trial

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Addresses

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    • Univ.-Klinik für Innere MedizinKlinische Abteilung für Endokrinologie und Diabetologie
    • Mr.  Univ.-Prof. Dr.  Thomas  Pieber 
    • Auenbruggerplatz 15
    • 8036  Graz
    • Austria
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    • Medizinische Universität Graz
    • Ms.  Ass. Prof. Dr.  Julia  Mader 
    • Auenbruggerplatz 2
    • 8036  Graz
    • Austria
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    • Medizinische Universität Graz
    • Ms.  Ass. Prof. Dr.  Julia  Mader 
    • Auenbruggerplatz 2
    • 8036  Graz
    • Austria
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Sources of Monetary or Material Support

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    • LKH Universitätsklinikum GrazAbteilung für Endokrinologie & Diabetologie
    • Auenbruggerplatz 15
    • 8036  Graz
    • Austria
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.