DigiDiab Evaluation Domiciliary Nursing Care

NCT ID: NCT06616779

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-04-15

Brief Summary

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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.

Detailed Description

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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

Conditions

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Type 2 Diabetes Type 2 Diabetes Mellitus (T2DM) Type 2 Diabetes, Insulin Requiring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GlucoTab Group

GlucoTab

Intervention Type 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.

Retrospective Control Group

Diabetes Treatment

Intervention Type OTHER

Diabetes Standard Care

Interventions

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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.

Intervention Type DEVICE

Diabetes Treatment

Diabetes Standard Care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Austrian Red Cross

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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DigiDiab Styria

Identifier Type: -

Identifier Source: org_study_id

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