DiabetesNCT01781533
Study to Test Software Algorithm for Insulin Therapy and New Glucose Sensor
A study testing algorithm in people with Diabetes, run by Medical University of Graz at 1 site in Austria.
Trial summary
To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- algorithm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2013to Jan 2015
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 75 years (both inclusive)
- Informed consent obtained after being advised of the nature of the study
- The subject has Type 1 diabetes (as defined by WHO) for at least 24 months
- The subject's HbA1c <= 10%
- Body Mass Index (BMI) <= 35 kg/m2
- The subject is treated with continuous subcutaneous insulin infusion for at least 3 month
Who cannot join
- Subject is actively enrolled in another clinical trial or took part in a study within 30 days
- Experienced recurrent severe hypoglycaemic unawareness
- Total daily insulin dose >= 1.4 IU/kg
- Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration
- Allergy against insulin Lispro
- A history of drug or alcohol dependence
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- Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator
- Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
- Patient is pregnant, or breast feeding during the period of the study
- Patient donated blood in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Single-centre, Non-controlled Feasibility Study Using a Software-algorithm Based Insulin Therapy to Control Blood Glucose in Type 1 Diabetic Patients
To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients.
- Conditions
- Diabetes
- Being tested
- algorithm
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
algorithmProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| algorithm | Experimental | Not described Receives: Procedure: algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of glucose values obtained every 15 min in predefined glucose ranges
Measured: 15 minutes
Secondary outcomes (2)
Injected insulin dose
Measured: 24 hours
Accuracy of the glucose monitoring unit
The absolute and relative difference between glucose monitoring readings and reference values (blood glucose) will be used to determine the accuracy of the monitoring unit
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pieber Thomas, MD, Medical University of Graz
- Investigators
- Thomas R Pieber, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781533
- Sponsor's protocol ID
- REACTbyALGO-1
- Status last verified
- Mar 2015
- First submitted
- 23 Jan 2013
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-centre, Non-controlled Feasibility Study Using a Software-algorithm Based Insulin Therapy to Control Blood Glucose in Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01781533
- Acronym / sponsor ID
- REACTbyALGO-1
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 Feb 2013 (estimated)
- 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.
To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| algorithm | Experimental | Procedure: algorithm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged 18 to 75 years (both inclusive)
- Informed consent obtained after being advised of the nature of the study
- The subject has Type 1 diabetes (as defined by WHO) for at least 24 months
- The subject's HbA1c <= 10%
- Body Mass Index (BMI) <= 35 kg/m2
Key exclusion criteria (10 listed)
- Subject is actively enrolled in another clinical trial or took part in a study within 30 days
- Experienced recurrent severe hypoglycaemic unawareness
- Total daily insulin dose >= 1.4 IU/kg
- Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration
- Allergy against insulin Lispro
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 |
|---|---|---|
| algorithm | Procedure or surgery | algorithm |
Primary outcome
the percentage of glucose values obtained every 15 min in predefined glucose ranges
Time frame: 15 minutes
2 secondary outcomes
Injected insulin dose
Time frame: 24 hours
Accuracy of the glucose monitoring unit
Time frame: 24 hours
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 18 Mar 2015.
- Related InfoLink provided by the sponsor.
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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.
Thomas R Pieber, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing algorithm in people with Diabetes, 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 6 inclusion and 10 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 18 Mar 2015. 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?
the percentage of glucose values obtained every 15 min in predefined glucose ranges (time frame: 15 minutes). 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 18 Mar 2015.