Diabetes MellitusNCT01512654
Personalized Glucose Predictive and Therapy Advisory System - DIAdvisor 2
A study testing Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor) in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by University Hospital, Montpellier at 3 sites in 3 countries.
Trial summary
The primary purpose of this study is to see whether a tool that predict blood glucose and suggest therapy advices can help type 1 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2008to Jun 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be aged between 18 (inclusive) and 70 years old
- Patients diagnosed with type 1 or type 2 diabetes according to WHO criteria for at least one year prior to study entry
- Patient treated by a basal-bolus insulin therapy using an external pump or multiple-daily injections. The insulin regimen has to be stable for the previous six months. NPH insulin use will not be acceptable.
- Patient should have stable diabetes with a HbA1c between ≥ 7.5 % and < 10.5 % with no keto-acidosis for the previous 6 months.
- Patient must have a Body Mass Index (BMI) lower than 35 Kg/m²
- Patient must be willing to undergo all study procedures
- Patient must be affiliated or beneficiary of a social medical insurance
- Patient has signed informed consent form prior to study entry
Who cannot join
- Patient is pregnant, or breast feeding during the period of the study
- Patient has impaired renal function with a creatinine blood concentration over 150 μmol/L
- Patient has a liver disease (ALAT, ASAT > 2 x upper limit of normal range)
- Patient is treated by sulfamides, GLP-1 analogues, DPP-IV inhibitors or glitazones
- Alcohol or drug addiction, as identified by investigator during screening visit
- Allergy to sensors or one of their components
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- Manifest psychological disorders
- Patient health status is not compatible with physical exercise
- Patient is actively enrolled in another clinical trial or was part of study within 30 days
- Persons deprived of freedom, adults protected by law or vulnerable persons
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Assessment of an Enhanced Version of a Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor-2) for Diabetic Patients Treated by Basal-Bolus Insulin Regimens
The primary purpose of this study is to see whether a tool that predict blood glucose and suggest therapy advices can help type 1 diabetic patients.
Read the detailed description
During this study, we would like to assess the efficacy in keeping blood glucose in a safe range (70-180 mg/dL) of the second generation of a Glucose Predictive and Therapy Advisory system in diabetic patients treated by basal-bolus insulin regimens using pumps or multiple daily injections. We want to compare the time spent in safe range while using the predictor and advisor outputs and when the patient is not using them. This is a randomized controlled crossover trial. Patient will come for two admissions of 3 days, one with the DIAdvisor system fully activated, and one with the prediction and advice features disabled.
- Being tested
- Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)
- Keywords
- diabetes, diadvisor, type 1 diabetes, type 2 diabetes, glucose prediction, cgm prediction, algorithm, therapy advices
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)Device
Glucose predictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians.
Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)Device
Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help.
| Study group | Role | What they receive |
|---|---|---|
| algorithm DIAdvisor activated | Other | Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help. Receives: Device: Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor) |
| algorithm of DIAdvisor disactivated | Other | Glucosepredictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians. Receives: Device: Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of total time spent by patients in safe range (70-180mg/dL)
The primary endpoint is the percentage of total time spent by patients in safe range (70-180mg/dL). A clinically significant benefit will be reached if an increase of at least 10% of total time in range is obtained while using DIAdvisor-2.
Measured: during 3 days with DIAdvisor 2
Secondary outcomes (6)
Percentage of total time spent in hypoglycemia (< 70 mg/dL)
Measured: during 3 days with DIAdvisor 2
Percentage of total of time spent in hyperglycemia (>180 mg/dL)
Measured: during 3 days with DIAdvisor 2
Mean of YSI blood glucose during total period, night time and meal periods
Measured: during the two 3 days-hospitalizations
Percentage paired glucose values
Percentage paired glucose values: Predicted glucose t+20min vs. real glucose t to t+20min in A\&B zones of EGA > 80% AND < 5% in E zone of EGA
Measured: during 3 days with DIAdvisor 2
Coherence between system advices and physician recommendations > 0.80
Measured: during 3 days with DIAdvisor 2
Score of patient survey regarding the acceptability of DIAdvisor-2 system
Measured: during 3 days with DIAdvisor 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startSep 2008
- Primary completionFeb 2009
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512654
- Sponsor's protocol ID
- 8266 3
- Other IDs
- ID-RCB : 2011-A00513-38
- Status last verified
- Dec 2014
- First submitted
- 29 Sep 2011
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an Enhanced Version of a Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor-2) for Diabetic Patients Treated by Basal-Bolus Insulin Regimens
- ClinicalTrials.gov ID
- NCT01512654
- Acronym / sponsor ID
- 8266 3
- Keywords
- diabetes, diadvisor, type 1 diabetes, type 2 diabetes, glucose prediction, cgm prediction, algorithm, therapy advices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Jan 2012 (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.
The primary purpose of this study is to see whether a tool that predict blood glucose and suggest therapy advices can help type 1 diabetic patients.
Detailed description
During this study, we would like to assess the efficacy in keeping blood glucose in a safe range (70-180 mg/dL) of the second generation of a Glucose Predictive and Therapy Advisory system in diabetic patients treated by basal-bolus insulin regimens using pumps or multiple daily injections. We want to compare the time spent in safe range while using the predictor and advisor outputs and when the patient is not using them. This is a randomized controlled crossover trial. Patient will come for two admissions of 3 days, one with the DIAdvisor system fully activated, and one with the prediction and advice features disabled.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| algorithm DIAdvisor activated | Other | Device: Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help. |
| algorithm of DIAdvisor disactivated | Other | Device: Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)Glucosepredictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient must be aged between 18 (inclusive) and 70 years old
- Patients diagnosed with type 1 or type 2 diabetes according to WHO criteria for at least one year prior to study entry
- Patient treated by a basal-bolus insulin therapy using an external pump or multiple-daily injections. The insulin regimen has to be stable for the previous six months. NPH insulin use will not be acceptable.
- Patient should have stable diabetes with a HbA1c between ≥ 7.5 % and < 10.5 % with no keto-acidosis for the previous 6 months.
- Patient must have a Body Mass Index (BMI) lower than 35 Kg/m²
Key exclusion criteria (10 listed)
- Patient is pregnant, or breast feeding during the period of the study
- Patient has impaired renal function with a creatinine blood concentration over 150 μmol/L
- Patient has a liver disease (ALAT, ASAT > 2 x upper limit of normal range)
- Patient is treated by sulfamides, GLP-1 analogues, DPP-IV inhibitors or glitazones
- Alcohol or drug addiction, as identified by investigator during screening visit
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 |
|---|---|---|
| Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)Glucose predictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians. | Device | algorithm of DIAdvisor disactivated |
| Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help. | Device | algorithm DIAdvisor activated |
Primary outcome
Percentage of total time spent by patients in safe range (70-180mg/dL)
Time frame: during 3 days with DIAdvisor 2
The primary endpoint is the percentage of total time spent by patients in safe range (70-180mg/dL). A clinically significant benefit will be reached if an increase of at least 10% of total time in range is obtained while using DIAdvisor-2.
6 secondary outcomes
Percentage of total time spent in hypoglycemia (< 70 mg/dL)
Time frame: during 3 days with DIAdvisor 2
Percentage of total of time spent in hyperglycemia (>180 mg/dL)
Time frame: during 3 days with DIAdvisor 2
Mean of YSI blood glucose during total period, night time and meal periods
Time frame: during the two 3 days-hospitalizations
Percentage paired glucose values
Time frame: during 3 days with DIAdvisor 2
Coherence between system advices and physician recommendations > 0.80
Time frame: during 3 days with DIAdvisor 2
Score of patient survey regarding the acceptability of DIAdvisor-2 system
Time frame: during 3 days with DIAdvisor 2
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 20 Oct 2021.
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor) in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by University Hospital, Montpellier at 3 sites in 3 countries.
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 8 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 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, France, Italy. 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?
Percentage of total time spent by patients in safe range (70-180mg/dL) (time frame: during 3 days with DIAdvisor 2). 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 20 Oct 2021.