Trial document




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  DRKS00012553

Trial Description

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Title

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

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Trial Acronym

ClinDiab-08

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URL of the Trial

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Brief Summary in Lay Language

Elderly patients with type 2 diabetes in geriatric care facilities are frequently not treated according to diabetes guideline recommendations. Guidelines recommend a diabetes therapy according to the individual health status of the elderly. The main goal of diabetes therapy in elderly persons is to avoid low blood glucose values (hypoglycaemia), but also high blood glucose values (hyperglycaemia) should be avoided.
It is the primary objective of this study to compare 2 different strategies of diabetes management in elderly patients with type 2 diabetes:
1. one group of patients will be treated with an Algorithm, which offers decision support for the insulin doses and the blood glucose measurement frequency. This algorithm is incorporated in a portable computer (the GlucoTab system).
2. the second group will be treated with Insulin standard therapy as judged by the treating physician. Diabetes therapy and blood glucose values will be documented in the GlucoTab system (no decision support).

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Brief Summary in Scientific Language

Background:
Up to 25% of all people aged 70 and older suffer from type 2 diabetes. Diabetes guidelines recommend to individualize diabetes targets and to simplify insulin therapy to avoid hypoglyceamia in elderly patients with diabetes.

Primary objective:
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

Study visit 1: Screening
After informed consent has been obtained, patients will be screened according to in- and exclusion criteria. Patients will be allocated to 3 groups according to health status.
All patients will be randomly assigned to intervention or control group.

Study visit 2: treatment
Intervention group:
Basal insulin will be started and titratied according to the basal insulin software algorithm in the GlucoTab system.
For very high blood glucose values GlucoTab recommends short-acting insulin.

Control group:
Study participants in the control group will receive standard insulin therapy as judged by the treating physician. This therapy will be documented by the health professionals using the GlucoTab system with the feature “eigene Therapie” without decision support.

Study visit 3: discharge
Treatment ends with hospital discharge or as judged by physician.
No follow-up visit is included in the study.

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Forwarding of patient-related data:

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012553
  •   2017/06/06
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  •   yes
  •   Approved
  •   29-359 ex 16/17, Ethikkommission der Medizinischen Universität Graz
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Secondary IDs

  •   2017-000955-25 
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Health Condition or Problem studied

  •   type 2 diabetes
  •   E11 -  Type 2 diabetes mellitus
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Interventions/Observational Groups

  •   Insulin glargine (Toujeo Solostar) once a day according to the GlucoTab Software Algorithm with decision support;
    if required Insulin glulisine (Apidra Solostar) as correctional insulin according to the GlucoTab Software Algorithm with decision support during hospital stay (max. 3 weeks)
  •   Insulin therapy as judged by the treating physician - only documentation with GlucoTab (no decision support)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

Mean percentage of FBGs in the FBG (fasting blood glucose) target range according to health status calculated by all FBGs measured ≥ 24 hours after start of therapy
When: after study has been completed all measured FBGs will be evaluated.
The primary endpoint will be measured according to the measured FBGs in the target range
The endpoint will be measured by the FBGs that are documented in the GlucoTab system

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Secondary Outcome

Number of episodes below individual glycaemic target range;
When: after study has been completed all measured BGs will be evaluated.
The endpoint will be measured according to the measured BG values below the target range
The endpoint will be measured by the BGs that are documented in the GlucoTab system;


Usability: Adherence to suggested long-acting insulin titration dose
When: after study has been completed all data will be evaluated
the administered insulin will be compared to the insulin dose suggestion of the GlucoTab system
the administered insulin dose will be compared to the insulin dose suggestion of the GlucoTab system - all data are documented in the GlucoTab system

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/06/14
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   100   Years
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Additional Inclusion Criteria

Informed consent obtained after being advised of the nature of the study; Male or female aged ≥ 65 years; Planned minimum stay of 1 week; Insulin planned as inpatient and/or discharge therapy; Type 2 diabetes; Fulfilled criteria for admission in acute geriatric care / remobilisation wards;

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Exclusion Criteria

Instable corticosteroid therapy (>5 mg per day); Known or suspected allergy to insulin glargine/ glulisine; Parenteral nutrition; Participation in another trial which could influence the software algorithm; Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient; Any mental condition rendering the patient incapable of giving his/her consent; Pregnancy;

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Addresses

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    • Medizinische Universität GrazKlinische Abteilung für Endokrinologie und Diabetologie
    • Mr.  Univ. Prof. Dr.  Thomas  Pieber 
    • Auenbruggerpatz 15
    • 8036  Graz
    • Austria
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    • Albert Schweitzer Klinik Graz
    • Mr.  Prim. Priv.Doz. Dr.  Walter  Schippinger 
    • Albert Schweitzer Gasse 36
    • 8020  Graz
    • Austria
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    • Medizinische Universität GrazKlinische Abteilung für Endokrinologie und Diabetologie
    • Ms.  MSc  Angela  Libiseller 
    • Auenbruggerplatz 15
    • 8036  Graz
    • Austria
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    • Albert Schweitzer Klinik Graz
    • Mr.  Prim. Priv.Doz. Dr.  Walter  Schippinger 
    • Albert Schweitzer Gasse 36
    • 8020  Graz
    • Austria
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Sources of Monetary or Material Support

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    • FFG - Österreichische Forschungsförderungsgesellschaft
    • 1090  Wien
    • Austria
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Status

  •   Recruiting complete, follow-up complete
  •   2018/09/28
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Trial Publications, Results and other Documents

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