Type 1 DiabetesIRTANCT04211220
Study to Assess the Metabolic Impact of IRTA© and Patients Satisfaction in Type 1 Diabetic Patients, Treated by Either Insulin Pump or Multiple Daily Insulin Injections, and Using Freestyle Libre®, a Real-time Continuous Glucose Monitoring
A study testing A decision support software in people with Type 1 Diabetes, run by Rennes University Hospital at 1 site in France.
Trial summary
A prospective monocentric " before and after " study, ruled in 2 periods of 3 months : during the first period, the patient will adjust insulin treatment as usual, during the second period, the patient will adjust insulin treatment with IRTA support Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- A decision support software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2020to 3 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age
- Patients with type 1 diabetes mellitus for more than 2 years
- Treated by either insulin pump for more than 6 months or multiple daily insulin injections.
- Using Freestyle Libre® for more than 3 months
- Accepting IRTA use
- Patient able to provide free and informed consent
- Patient able to provide written non-disclosure agreement
Who cannot join
- Pregnancy, breastfeeding or pregnancy project in the future 6 months
- Patients with no smart phone or internet access
- Patients legally protected (under judicial protection, guardianship or supervision)
- Patients with acute illness (psychiatric, infection, cancer,…)
- Patients using another CGM system (Enlite® or Dexcom G4®)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Insulin Real-Time Advisor (IRTA©): a Decision Support Software for Insulin Therapy Combined With Freestyle Libre®, a Continuous Glucose Monitoring System: Glycemic Impact and Satisfaction in Type 1 Diabetic Patients
A prospective monocentric " before and after " study, ruled in 2 periods of 3 months : during the first period, the patient will adjust insulin treatment as usual, during the second period, the patient will adjust insulin treatment with IRTA support
Read the detailed description
Freestyle Libre® continuous glucose monitoring (CGM) system may improve glycemic control. However, this system contributes to the complexity of insulin adjustment by the diversity of the data delivered by CGM system.
Insulin Real-Time Advisor (IRTA©), a decision support software, has been developed in order to guide patients in the adaptation of their treatment according to CGM data. IRTA© provides advice applicable to thousand situations according to six parameters: glucose level, trend arrows, meals, physical activity, before bedtime, time since the previous bolus.
Type of advice :
- Insulin injection (carb and correction)
- To continue treatment without modification
- To lower the insulin dose (temporary basal rate)
- Sugar intake advice
- Glucose level control with CGM, self-monitor blood glucose, blood ketones monitor
- To change catheter for patients treated by insulin pump.
- Conditions
- Type 1 Diabetes
- Being tested
- A decision support software
- Keywords
- Real time continuous glucose monitoring, Decision support software
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A decision support softwareOther
Insulin pump Continuous glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | Experimental | Not described Receives: Other: A decision support software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent in 70-180mg/dl (time in range) in the last month of each period of the study (without and then with IRTA©)
Assessment of the metabolic impact of IRTA© on "time in range" (time spent in the standard glucose range between 70-180mg/dl, ie 3.9-10mmol/l) in type 1 diabetic patients, treated by either insulin pump or multiple daily insulin injections, and using Freestyle Libre®.
Measured: 6 months
Secondary outcomes (13)
Comparison of HbA1c level at the end of each period of the study (without / with IRTA©)
Blood sample at inclusion, 3 months and 6 months
Measured: 6 months
Time spent in glucose level higher than 250 mg/dl
Measured: 6 months
Time spent in glucose level higher than 180 mg/dl
Measured: 6 months
Time spent in glucose level lower than 70 mg/dl
Measured: 6 months
Time spent in glucose level lower than 54 mg/dl
Measured: 6 months
Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)
Measured: 6 months
Percentage of time spent with or without CGM
Measured: 6 months
Glycemic variability
Measured: 6 months
Patients' satisfaction related to CGM and the impact of IRTA© on this satisfaction
CGM Satisfaction (CGM-SAT) 44-item questionnaire. Higher scores reflect more favorable impact of, and satisfaction with, CGM use.
Measured: 6 months
Patients' satisfaction related to IRTA©
Satisfaction questionnaire: 5-point Likert scale (1 = strongly agree; 5 = strongly disagree) with each of 18 items.
Measured: 6 months
Number of connections to the IRTA system
Measured: 6 months
Number of advice given by the IRTA system
Measured: 6 months
Type of advice given by the IRTA system that is more often asked
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start9 Jan 2020
- Primary completion3 Mar 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A decision support software
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211220
- Sponsor's protocol ID
- 35RC19_8858_IRTA
- Acronym
- IRTA
- Status last verified
- Aug 2021
- First submitted
- 20 Dec 2019
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Insulin Real-Time Advisor (IRTA©): a Decision Support Software for Insulin Therapy Combined With Freestyle Libre®, a Continuous Glucose Monitoring System: Glycemic Impact and Satisfaction in Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT04211220
- Acronym / sponsor ID
- IRTA / 35RC19_8858_IRTA
- Conditions
- Type 1 Diabetes
- Keywords
- Real time continuous glucose monitoring, Decision support software
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 26 Dec 2019 (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.
A prospective monocentric " before and after " study, ruled in 2 periods of 3 months : during the first period, the patient will adjust insulin treatment as usual, during the second period, the patient will adjust insulin treatment with IRTA support
Detailed description
Freestyle Libre® continuous glucose monitoring (CGM) system may improve glycemic control. However, this system contributes to the complexity of insulin adjustment by the diversity of the data delivered by CGM system.
Insulin Real-Time Advisor (IRTA©), a decision support software, has been developed in order to guide patients in the adaptation of their treatment according to CGM data. IRTA© provides advice applicable to thousand situations according to six parameters: glucose level, trend arrows, meals, physical activity, before bedtime, time since the previous bolus.
Type of advice :
- Insulin injection (carb and correction)
- To continue treatment without modification
- To lower the insulin dose (temporary basal rate)
- Sugar intake advice
- Glucose level control with CGM, self-monitor blood glucose, blood ketones monitor
- To change catheter for patients treated by insulin pump.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A decision support software
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | Experimental | Other: A decision support software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ≥ 18 years of age
- Patients with type 1 diabetes mellitus for more than 2 years
- Treated by either insulin pump for more than 6 months or multiple daily insulin injections.
- Using Freestyle Libre® for more than 3 months
- Accepting IRTA use
Key exclusion criteria (5 listed)
- Pregnancy, breastfeeding or pregnancy project in the future 6 months
- Patients with no smart phone or internet access
- Patients legally protected (under judicial protection, guardianship or supervision)
- Patients with acute illness (psychiatric, infection, cancer,…)
- Patients using another CGM system (Enlite® or Dexcom G4®)
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 |
|---|---|---|
| A decision support softwareInsulin pump Continuous glucose monitoring | Other | Type 1 diabetes |
Primary outcome
Percentage of time spent in 70-180mg/dl (time in range) in the last month of each period of the study (without and then with IRTA©)
Time frame: 6 months
Assessment of the metabolic impact of IRTA© on "time in range" (time spent in the standard glucose range between 70-180mg/dl, ie 3.9-10mmol/l) in type 1 diabetic patients, treated by either insulin pump or multiple daily insulin injections, and using Freestyle Libre®.
13 secondary outcomes
Comparison of HbA1c level at the end of each period of the study (without / with IRTA©)
Time frame: 6 months
Time spent in glucose level higher than 250 mg/dl
Time frame: 6 months
Time spent in glucose level higher than 180 mg/dl
Time frame: 6 months
Time spent in glucose level lower than 70 mg/dl
Time frame: 6 months
Time spent in glucose level lower than 54 mg/dl
Time frame: 6 months
Number of incidents (severe hypoglycemia, diabetic ketoacidosis, hospitalizations related to poor glycemic control)
Time frame: 6 months
Percentage of time spent with or without CGM
Time frame: 6 months
Glycemic variability
Time frame: 6 months
Patients' satisfaction related to CGM and the impact of IRTA© on this satisfaction
Time frame: 6 months
Patients' satisfaction related to IRTA©
Time frame: 6 months
Number of connections to the IRTA system
Time frame: 6 months
Number of advice given by the IRTA system
Time frame: 6 months
Type of advice given by the IRTA system that is more often asked
Time frame: 6 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 22 Aug 2022.
- Individual participant dataSharing planned: No
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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?
A study testing A decision support software in people with Type 1 Diabetes, run by Rennes University Hospital at 1 site in France.
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 7 inclusion and 5 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 22 Aug 2022. 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 France. 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 time spent in 70-180mg/dl (time in range) in the last month of each period of the study (without and then with IRTA©) (time frame: 6 months). 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 22 Aug 2022.