Status:
TERMINATED
Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Cystic Fibrosis-related Diabetes
Eligibility:
All Genders
10+ years
Phase:
PHASE4
Brief Summary
Cystic fibrosis related diabetes (CFRD) is a major factor of morbidity and mortality at all disease stages. Insulin deficiency has serious clinical consequences by increasing malnutrition, since prote...
Detailed Description
The investigators hypothesis that post prandial administration of Insulin faster-acting aspart insulin in patients with CFRD may contribute to a better metabolic control with a decrease of hypoglycaem...
Eligibility Criteria
Inclusion
- Patient with cystic fibrosis related diabetes aged over 10 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 (if the subject is a minor, the consent must be signed by the 2 legal representative and the patient if he/she is able to give consent)
Exclusion
- 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
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04381429
Start Date
August 17 2020
End Date
January 20 2025
Last Update
March 5 2025
Active Locations (1)
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1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091