Type 1 Diabetes
Conditions
Keywords
Real time continuous glucose monitoring, decision support software, smartphone application.
Brief 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.
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.
Interventions
Sponsors
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of similarity between patient decisions and IPRA© advices | 3 months | Assessment of patient satisfaction about using IPRA© and their frequency of use. Recording of the changes proposed by the expert patients. |
| Assessment of changes proposed by the experts | 3 months | — |
| Assessment of frequency of software use | 3 months | — |
| Assessment of patient satisfaction | 3 months | — |
Countries
France
Outcome results
None listed