DigiDiab Pilot Spain - Nursing Home and Domiciliary Nursing Care
NCT ID: NCT06605859
Last Updated: 2025-08-03
Study Results
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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RECRUITING
40 participants
OBSERVATIONAL
2025-04-08
2025-09-15
Brief Summary
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It provides a therapy algorithm for subcutaneous basal insulin therapy of patients with type 2 diabetes, which will be used in this study.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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GlucoTab Prospective Group
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 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.
Retrospective Control Group
Diabetes Treatment
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 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.
Diabetes Treatment
Diabetes Standard Care
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)
* Residents of participating nursing homes/domiciliary nursing care in the region of Camp de Tarragona (Spain).
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Locations
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IDIAP Jordi Gol
Tarragona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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230206 EIT Health-nursing home
Identifier Type: -
Identifier Source: org_study_id
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