Type 1 DiabetesIPRANCT01883024
Insulin Pump-RT Advisor (IPRA©): a Decision Support Software for Diabetic Patients Treated by Insulin Pump and Using Continuous Glucose Monitoring. Experimental Study. Evaluation by an Expert Patient Panel.
A study testing A decision support software, Insulin Pump and Continuous glucose monitoring in people with Type 1 Diabetes, run by Rennes University Hospital at 1 site in France.
Trial summary
The purpose of the study is to assess the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring. 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, Insulin Pump and Continuous glucose monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Sep 2013
- 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 for more than 2 years,
- patients treated by insulin pump for more than 6 months,
- patients using of real-time continuous glucose monitoring for more than 3 months,
- patients able to evaluate the IPRA advices by connecting to IPRA© application 30 times a week,
- patient able to provide written informed consent,
- patient able to provide written non-disclosure agreement
Who cannot join
- pregnancy or breastfeeding,
- current infectious disease,
- patients with no smartphone® or Internet access,
- adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud
Rennes, 35230
About this study
Official title: Prospective Study, Insulin Pump-RT Advisor (IPRA©): a Decision Support Software for Diabetic Patients Treated by Insulin Pump and Using Continuous Glucose Monitoring. Experimental Study. Evaluation by an Expert Patient Panel.
The purpose of the study is to assess the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.
Read the detailed description
Patients will be asked to evaluate the IPRA advices by connecting to IPRA© application by using their smartphone, 30 times a week for two weeks. At the end of this two week period, a satisfaction questionnaire will be completed.
- Conditions
- Type 1 Diabetes
- Being tested
- A decision support software, Insulin Pump, Continuous glucose monitoring
- Keywords
- Real time continuous glucose monitoring, decision support software, smartphone application.
- 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 PumpOther
Continuous glucose monitoringOther
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | Other | Not described Receives: Other: A decision support software; Other: Insulin Pump; Other: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient agreement with the IPRA© advices: global rate of agreement, according to advice subtypes, according to blood glucose levels, according to the situations (pre or post-meal, bedtime)
Assessment of the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.
Measured: 3 months
Secondary outcomes (4)
Assessment of similarity between patient decisions and IPRA© advices
Assessment of patient satisfaction about using IPRA© and their frequency of use.
Recording of the changes proposed by the expert patients.
Measured: 3 months
Assessment of changes proposed by the experts
Measured: 3 months
Assessment of frequency of software use
Measured: 3 months
Assessment of patient satisfaction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Guilhem, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883024
- Sponsor's protocol ID
- 2013-A00495-40
- Other IDs
- LOC 1308
- Acronym
- IPRA
- Status last verified
- May 2023
- First submitted
- 14 Jun 2013
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Esvant A, Lefebvre MA, Campillo-Gimenez B, Lannes M, Delamarre D, Guilhem I, Poirier JY. A Mobile Application Guiding Patients With Type 1 Diabetes Using Sensor-Augmented Insulin Pump Therapy. J Diabetes Sci Technol. 2016 Jun 28;10(4):985-6. doi: 10.1177/1932296816633486. Print 2016 Jul. No abstract available.
PubMed 26902791
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study, Insulin Pump-RT Advisor (IPRA©): a Decision Support Software for Diabetic Patients Treated by Insulin Pump and Using Continuous Glucose Monitoring. Experimental Study. Evaluation by an Expert Patient Panel.
- ClinicalTrials.gov ID
- NCT01883024
- Acronym / sponsor ID
- IPRA / 2013-A00495-40
- Conditions
- Type 1 Diabetes
- Keywords
- Real time continuous glucose monitoring, decision support software, smartphone application.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Jun 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.
The purpose of the study is to assess the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.
Detailed description
Patients will be asked to evaluate the IPRA advices by connecting to IPRA© application by using their smartphone, 30 times a week for two weeks. At the end of this two week period, a satisfaction questionnaire will be completed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | Other | Other: A decision support software, Other: Insulin Pump, Other: Continuous glucose monitoring |
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 for more than 2 years,
- patients treated by insulin pump for more than 6 months,
- patients using of real-time continuous glucose monitoring for more than 3 months,
- patients able to evaluate the IPRA advices by connecting to IPRA© application 30 times a week,
Key exclusion criteria (4 listed)
- pregnancy or breastfeeding,
- current infectious disease,
- patients with no smartphone® or Internet access,
- adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
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 software | Other | Type 1 diabetes |
| Insulin Pump | Other | Type 1 diabetes |
| Continuous glucose monitoring | Other | Type 1 diabetes |
Primary outcome
Patient agreement with the IPRA© advices: global rate of agreement, according to advice subtypes, according to blood glucose levels, according to the situations (pre or post-meal, bedtime)
Time frame: 3 months
Assessment of the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.
4 secondary outcomes
Assessment of similarity between patient decisions and IPRA© advices
Time frame: 3 months
Assessment of changes proposed by the experts
Time frame: 3 months
Assessment of frequency of software use
Time frame: 3 months
Assessment of patient satisfaction
Time frame: 3 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 24 May 2023.
- Results publication: PubMed 26902791Esvant A, Lefebvre MA, Campillo-Gimenez B, Lannes M, Delamarre D, Guilhem I, Poirier JY. A Mobile Application Guiding Patients With Type 1 Diabetes Using Sensor-Augmented Insulin Pump Therapy. J Diabetes Sci Technol. 2016 Jun 28;10(4):985-6. doi: 10.1177/1932296816633486. Print 2016 Jul. No abstract available.
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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.
Isabelle Guilhem principal investigator
Rennes University Hospital
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, Insulin Pump and Continuous glucose monitoring 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 4 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 24 May 2023. 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?
Patient agreement with the IPRA© advices: global rate of agreement, according to advice subtypes, according to blood glucose levels, according to the situations (pre or post-meal, bedtime) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01883024, which also lists 1 linked publication.
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 24 May 2023.