Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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 protein and lipid catabolism is accelerated in chronic infections. Traditionally, insulin is injected before a meal. Yet, in these patients with highly varied and often staggered nutritional intakes, insulin injection can result in an increased risk of postprandial hypoglycaemia, all the more so as CF patients exhibit decreased glucagon secretion.

Recent progress in the development of new insulins mimicking the physiological secretion more closely has led to ultra-fast insulins (fast aspart), allowing for postprandial hyperglycaemia to be better controlled. In Type 1 diabetics treated with basal-bolus, faster-acting aspart insulin injected after a meal enabled metabolic control comparable to injection of aspart insulin prior to the meal. Fast apart insulin is of particular interest with regard to CFRD, wherein postprandial hyperglycaemia occurs early. In CFRD, these insulins are likewise advantageous in that they can be injected after the meal, thus permitting more flexibility in patients with highly varied diets. Moreover, the insulin dose can be adapted depending on dietary intake, thus preventing hypoglycaemia secondary to highly-varied carbohydrate intakes. Due to its flexibility, this insulin therapy is likely to be better accepted by patients with cystic fibrosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Strasbourg, France
• Treatments: Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Long-Acting

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)

• 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 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