DigiDiab Evaluation Domiciliary Nursing Care

NCT06616779 | Completed

• 1 other identifier: DigiDiab Styria
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Efficacy - mean percentage of Fasting Blood Glucose

  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 Outcomes (3)

• Safety - number of hypoglycaemic events

  at the end of the study, on average three months

• Efficacy - mean pre-breakfast blood glucose values

  at the end of the study, on average three months

• Usability

  at the end of the study, on average three months

Study Arms (2)

GlucoTab Group

Device: GlucoTab

Retrospective Control Group

Other: Diabetes Treatment

Interventions

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.

GlucoTab Group

Diabetes Treatment OTHER

Diabetes Standard Care

Retrospective Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Austrian Red Cross

Graz, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 27, 2024
• Study Start: November 30, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 15, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

AU (1)