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Completed

NCT Number: NCT06616779

DigiDiab Evaluation Domiciliary Nursing Care

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus (T2DM) Type 2 Diabetes, Insulin Requiring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Austrian Red Cross

Graz, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GlucoTab

Device

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.

Diabetes Treatment

Other

Diabetes Standard Care

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Usability

    Time frame: at the end of the study, on average three months

    Percentage of insulin dose injections performed according to the GlucoTab system

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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