DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care
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
1 other identifier
observational
40
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2024
CompletedFirst Posted
Study publicly available on registry
September 20, 2024
CompletedStudy Start
First participant enrolled
April 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2025
CompletedAugust 3, 2025
July 1, 2025
5 months
September 18, 2024
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy - mean percentage of fasting blood glucose in target range
Efficacy is assessed by evaluating the Mean percentage of Fasting Blood Glucose in the target range 80 - 180 mg/dl
≥ 24 hours after start of the therapy by using the GlucoTab system
Secondary Outcomes (3)
Usability
at the end of the study, on average three months
Safety - number of hypoglycaemic events
at the end of the study, on average three months
Efficacy - mean pre-breakfast blood glucose
at the end of the study, on average three months
Study Arms (2)
GlucoTab Prospective Group
Retrospective Control Group
Interventions
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 nurses of the nursing homes/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.
Eligibility Criteria
Non-critically ill patients with type 2 diabetes in the participating nursing homes/domiciliary nursing care who require s.c. insulin therapy
You may qualify if:
- 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).
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IDIAP Jordi Gol
Tarragona, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2024
First Posted
September 20, 2024
Study Start
April 8, 2025
Primary Completion
September 15, 2025
Study Completion
September 15, 2025
Last Updated
August 3, 2025
Record last verified: 2025-07