DigiDiab Evaluation Domiciliary Nursing Care

Not yet recruiting

• Conditions: Type 2 Diabetes; Type 2 Diabetes Mellitus (T2DM); Type 2 Diabetes, Insulin Requiring
• Interventions: Device: GlucoTab; Other: Diabetes Treatment

• Registration Number: NCT06616779
• Lead Sponsor: Medical University of Graz

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.

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 Timeline

• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Study Start: 2024-11-30
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GlucoTab Group	GlucoTab	-
Retrospective Control Group	Diabetes Treatment	-

Primary Outcome Measures

Name	Time	Method
Efficacy - mean percentage of Fasting Blood Glucose	≥ 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 Outcome Measures

Name	Time	Method
Safety - number of hypoglycaemic events	at the end of the study, on average three months	Safety is assessed by evaluating the number of hypoglycaemic events
Efficacy	at the end of the study, on average three months	mean pre-breakfast blood glucose
Usability	at the end of the study, on average three months	Percentage of insulin dose injections performed according to the GlucoTab system