Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes (MIRE)
Cystic Fibrosis-related Diabetes
About this trial
This is an interventional treatment trial for Cystic Fibrosis-related Diabetes
Eligibility Criteria
Inclusion Criteria:
- Patient with cystic fibrosis related diabetes aged over 18 years (no upper age limite)
- Patient treated by multiple insulin injections (minimal three insulin injections per day or basal bolus insulin regimen) or insulin pump
- Patient with CGM from over 3 months (at the signature of the study's informed consent) or patient not wearing a CGM device, but agreeing a CGM at the inclusion and at the end of each treatment period of 3 months
- Naive patient of Fiasp or patient under Fiasp, having carried out a run-in period of one month with rapid acting insulin treatment
- Affiliated to a social security scheme
- Subject able to understand the objectives and the risks related to the research and to give a dated and signed informed consent
- Subject having been informed of the results of the prior medical examination
- Written informed consent, dated and signed before initiating any trial-related procedure
Exclusion Criteria:
- Patient with type 1 or type 2 diabetes
- Patient with cystic fibrosis related diabetes treated with 2 injections / day
- Patient with an HbA1C greater than 12% who demonstrate therapeutic non-compliance
- Patient pregnant (positive urinary pregnancy test) or wishing to pregnancy
- Contraindication to Aspart insulin
- Patient on lung transplant waiting list or transplanted within one year prior to the inclusion visit
- Patient who started treatment with Trikafta® within 3 months prior to the inclusion visit
- Patient who cannot be followed during 12 months
- Subject in exclusion period (determined by previous or current clinical study)
- Impossibility of giving the subject enlightened information (subject in emergency situation, difficulties of understanding, cognitive impairment...)
- Subject under the protection of justice
- Subject under guardianship or curatorship
Sites / Locations
- Hôpitaux Universitaires de StrasbourgRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Group 1: A-F-A-F
Groupe 2: F-A-F-A
The study is an open, randomized, two-treatment - 4 periods of 3 months - 2 group cross-over superiority study. All patients will test both insulin treatments (A and F) in alternating periods. The patients of group 1 will start with pre-prandial aspart insulin (NovoRapid). Each treatment period will last 3 months.
The study is an open, randomized, two-treatment - 4 periods of 3 months - 2 group cross-over superiority study. All patients will test both insulin treatments (A and F) in alternating periods. The patients of group 2 will start with post prandial Faster-acting aspart insulin (FIASP).