DigiDiab Evaluation Domiciliary Nursing Care

July 29, 2025 updated by: Medical University of Graz

An Open, Single-centre, Non-interventional Study of the CE-marked Medical Device GlucoTab, According to Intended Use Without Additional Invasive and Stressful Measures

GlucoTab is a stand-alone software system to support healthcare professionals in the care of patients with diabetes mellitus or newly diagnosed hyperglycaemia who are treated with insulin and/or other glucose-lowering drugs or of patients only requiring glucose monitoring.

It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes, which will be used in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

GlucoTab: The CE-marked medical device GlucoTab is a system designed to support healthcare personnel in managing insulin therapy for patients with diabetes.

In this study, only the GlucoTab algorithm supported basal therapy will be used, which is intended for patients with Type 2 diabetes in domiciliary nursing care requiring insulin therapy.

GlucoTab has a CE certificate, will be used according to its intended purpose and no additional burdensome or invasive interventions are planned

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Austrian Red Cross

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Non-critically ill patients with type 2 diabetes receiving domiciliary nursing care who require s.c. insulin therapy

Description

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

Exclusion Criteria:

  • type 1 diabetes mellitus
  • intravenous insulin therapy
  • hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
  • continuous subcutaneous insulin infusion
  • gestational diabetes or pregnancy
  • known or suspected allergy to insulin
  • total parenteral nutrition
  • any mental condition rendering the patient incapable of giving his/her consent
  • any disease or condition which according to the investigator would interfere with the trial or the safety of the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective Control Group
Other: Diabetes Treatment
Diabetes Standard Care
GlucoTab Group
Device: GlucoTab
Insulin therapy will be started and adjusted according to the GlucoTab system with incorporated software algorithm. The goal of the basal insulin algorithm is to maintain blood glucose (BG) within acceptable targets according to the predefined health status. For a limited time period after therapy start, three BG measurements per day are suggested by the algorithm to determine blood glucose. Insulin dosage titration will be performed according to the algorithm in GlucoTab under supervision of the nurses of domiciliary nursing care. Correctional bolus insulin will be administered at defined time-points according to BG targets in the predefined health status. Nurses and nursing assistants will be trained in the use of the GlucoTab system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - mean percentage of Fasting Blood Glucose
Time Frame: ≥ 24 hours after start of the therapy by using the GlucoTab system
Efficacy is assessed by evaluating the mean percentage of Fasting Blood Glucose (FBG) in the FBG target range 80 - 180 mg/dl
≥ 24 hours after start of the therapy by using the GlucoTab system

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - number of hypoglycaemic events
Time Frame: at the end of the study, on average three months
Safety is assessed by evaluating the number of hypoglycaemic events
at the end of the study, on average three months
Usability
Time Frame: at the end of the study, on average three months
Percentage of insulin dose injections performed according to the GlucoTab system
at the end of the study, on average three months
Efficacy - mean pre-breakfast blood glucose values
Time Frame: at the end of the study, on average three months
Efficacy is further assessed by the measurement of mean pre-breakfast blood glucose values
at the end of the study, on average three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2024

Primary Completion (Actual)

March 31, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DigiDiab Styria

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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