Type 2 DiabetesNCT06616779
DigiDiab Evaluation Domiciliary Nursing Care
An observational study of Type 2 Diabetes and Type 2 Diabetes Mellitus (T2DM), run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes, Insulin Requiring
- What is being tested?
- GlucoTab and Diabetes Treatment
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 30 Nov 2024to 15 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-critically ill patients with type 2 diabetes receiving domiciliary nursing care who require s.c. insulin therapy
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Single-centre, Non-interventional Study of the CE-marked Medical Device GlucoTab, According to Intended Use Without Additional Invasive and Stressful Measures
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.
Read the 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
- Being tested
- GlucoTab, Diabetes Treatment
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoTabDevice
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.
Diabetes TreatmentOther
Diabetes Standard Care
| Study group | Role | What they receive |
|---|---|---|
| GlucoTab Group | Not described Receives: Device: GlucoTab | |
| Retrospective Control Group | Not described Receives: Other: Diabetes Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: ≥ 24 hours after start of the therapy by using the GlucoTab system
Secondary outcomes (3)
Safety - number of hypoglycaemic events
Safety is assessed by evaluating the number of hypoglycaemic events
Measured: at the end of the study, on average three months
Efficacy - mean pre-breakfast blood glucose values
Efficacy is further assessed by the measurement of mean pre-breakfast blood glucose values
Measured: at the end of the study, on average three months
Usability
Percentage of insulin dose injections performed according to the GlucoTab system
Measured: at the end of the study, on average three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start30 Nov 2024
- Primary completion31 Mar 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616779
- Sponsor's protocol ID
- DigiDiab Styria
- Status last verified
- Jul 2025
- First submitted
- 19 Sep 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-centre, Non-interventional Study of the CE-marked Medical Device GlucoTab, According to Intended Use Without Additional Invasive and Stressful Measures
- ClinicalTrials.gov ID
- NCT06616779
- Acronym / sponsor ID
- DigiDiab Styria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GlucoTab Group | – | Device: GlucoTab |
| Retrospective Control Group | – | Other: Diabetes Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-critically ill patients with type 2 diabetes receiving domiciliary nursing care who require s.c. insulin therapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucoTabInsulin 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. | Device | GlucoTab Group |
| Diabetes TreatmentDiabetes Standard Care | Other | Retrospective Control Group |
Primary outcome
Efficacy - mean percentage of Fasting Blood Glucose
Time frame: ≥ 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
3 secondary outcomes
Safety - number of hypoglycaemic events
Time frame: at the end of the study, on average three months
Efficacy - mean pre-breakfast blood glucose values
Time frame: at the end of the study, on average three months
Usability
Time frame: at the end of the study, on average three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Type 2 Diabetes Mellitus (T2DM), run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - mean percentage of Fasting Blood Glucose (time frame: ≥ 24 hours after start of the therapy by using the GlucoTab system). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.