| Trial ID: | L2730 |
| Source ID: | NCT04381429
|
| Associated Drug: |
A-F-A-F (Novorapid-Fiasp-Novorapid-Fiasp)
|
| Title: |
Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes
|
| Acronym: |
MIRE
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Cystic Fibrosis-related Diabetes
|
| Interventions: |
DRUG: A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP)|DRUG: F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)
|
| Outcome Measures: |
Primary: 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., This measurement is assessed at the end of each treatment period of 3 months (the last 2 weeks of the period of 3 months). Month 3, month 6, month 9 and month 12. | Secondary: Other CGM parameters: mean glucose value per day (mg/dl), screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12|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, screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12|Other CGM parameters: time in range of blood glucose >180, >140 <70mg/dl, screening(Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3(3 months after inclusion)-Month 6-Month 9-Month 12|Hypoglycaemic events experienced by the patient - 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, Inclusion visit (Day0)-visit Month 3(3 months after inclusion visit)-Visit Month 6-Month 9-Month 12|Markers of nutritional status: Body Mass Index (BMI), visit (Day 0 to 3 months to Day 0-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12|Markers of nutritional status : bioelectrical impedance - Albumin and Pre albumin, visit (Day 0 to 3 months to Day 0-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12|Markers of nutritional status : Albumin and Pre albumin (g/l), visit (Day 0 to 3 months to Day 0-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12|Markers of metabolic status: HbA1c (mmol/l and %), screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12|Markers of metabolic status: daily exogenous need of insulin (UI/day), screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12|Assessment of respiratory function parameters : FEV1, CV (L and %), screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12|Assessment of respiratory function parameters : O2 saturation (%), screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12|Assessment of respiratory function parameters : Number of cures of IV antibiotics per year (collect this information at each visit), screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12|Number patients with severe hypoglycaemia and serious adverse events, Inclusion visit (Day 0)-visit Month 3(3 months after inclusion visit)-Visit Month 6-Month 9-Month 12|Other CGM parameters: Time in range of blood glucose 70-140 mg/dl, screening visit (Day 0 to 3 months to Day 0)-Inclusion visit (Day 0)-visit Month 3 (3 months after inclusion visit)-Visit Month 6-Month 9-Month 12
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Strasbourg, France
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
38
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-08-17
|
| Completion Date: |
2025-01-20
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-05
|
| Locations: |
Hôpitaux Universitaires de Strasbourg, Strasbourg, 67091, France
|
| URL: |
https://clinicaltrials.gov/show/NCT04381429
|
