DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GlucoTab, Diabetes Treatment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open, Multicentre, Prospective, Non-interventional Study of the CE-marked Medical Device GlucoTab in Nursing Homes and Domiciliary Nursing Care, According to Intended Use Without Additional Invasive and Stressful Measures
Overview
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 basalinsulin therapy will be used, which is intended for patients with Type 2 diabetes in domiciliary nursing care and nursing homes requiring insulin therapy.
Interventions
- 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 within acceptable targets according to the predefined health status. For a limited time period after therapy start, three 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 nurse - Other Diabetes Treatment
Diabetes Standard Care
Primary outcome measures
- Efficacy - mean percentage of fasting blood glucose in target range [Time frame: ≥ 24 hours after start of the therapy by using the GlucoTab system]
Secondary outcome measures (3)
- Usability [Time frame: at the end of the study, on average three months]
- Safety - number of hypoglycaemic events [Time frame: at the end of the study, on average three months]
- Efficacy - mean pre-breakfast blood glucose [Time frame: at the end of the study, on average three months]
Eligibility criteria
Inclusion criteria
- Elderly people, willing to be treated with a basal insulin therapy according to the GlucoTab system
- 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)
- Residents of participating nursing homes/domiciliary nursing care in the region of Camp de Tarragona (Spain).
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- IDIAP Jordi Gol — Tarragona
Identifiers
NCT: NCT06605859 · 230206 EIT Health-nursing home