CFDB - Cystic Fibrosis DataBase

ongoing trials trial from www.clinicaltrials.gov

Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes - Phase 4 - Not yet recruiting

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment

Participants

Cystic Fibrosis-related Diabetes - 18 Years and older   (Adult, Older Adult)

Interventions

Drug: A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP)|Drug: F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)

Outcome measures

Change of time in range of blood glucose variation (70-180 mg/dl) versus baseline at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months) is assessed.|Other CGM parameters: mean glucose value-mean glucose value 2h post meal|Other CGM parameters: glucose area under the curve for glucose value>180mg/dl - number of glucose values<70 mg/dl-number of glucose values<53mg/dl|Other CGM parameters: time in range of blood glucose>180<70mg/dl|Hypoglycaemic events - number of symptomatic hypoglycaemic events under 70 mg/dl par mois - number of major hypoglycaemic events per year - number of nocturnal hypoglycaemic events per month|Markers of nutritional status : subjective clinical Global Assessment (SGA) according to Detsky questionnaire|Markers of nutritional status: Body Mass Index (BMI)|Markers of nutritional status : bioelectrical impedance - Albumin and Pre albumin|Markers of nutritional status : Albumin and Pre albumin (g/l)|Markers of metabolic status: HbA1c (mmol/l and %)|Markers of metabolic status: daily exogenous need of insulin (UI/day)|Assessment of respiratory function parameters : FEV1, CV (L and %)|Assessment of respiratory function parameters : O2 saturation (%)|Assessment of respiratory function parameters : Number of cures of IV antibiotics per year (collect this information at each visit)|Assessment of respiratory function parameters : 6-minute walk test (6 MWT)|Number patients with severe hypoglycaemia and serious adverse events

Keywords: Adult; Diabetes Mellitus; Gastrointestinal Diseases; Hypoglycemic Agents; Insulin; Pancreatic Diseases; pharmacological_intervention; Oral;