Efficacy of domperidone (a prokinetic agent) on time in range in digestively asymptomatic type I diabetic patients with delayed gastric emptying

Type 1 Diabetic patients

The primary endpoint of this study is the difference of percentages of time spent within the TIR glycemic target range (70-180 mg/dL) recorded over 14 days under prokinetic treatment (domperidone) or placebo in T1D patients with gastroparesis and inadequate glycemic control

Variation in glycemic control criteria between domperidone and placebo (measurement of differences) o HbA1c assay o Plasma fructosamine assay, o number of hypoglycemic episodes, including severe ones, o percentage of time spent in hypoglycemia (<70mg/dL), o percentage of time spent in hyperglycemia (>180mg/dL), o coefficient of glycemic variability, o GMI o TIR, TBR, TAR, CV for each meal; o Insulin dose o Pre- and post-treatment gastric emptying data Tlag, T1/2, Clinical and paraclinical data in each group of T1D patients with or without delayed gastric emptying such as: -Age,sex,duration of diabetes,... -Total insulin dose,treatment modalities -Complications of diabetes: retinopathy,neuropathy,nephropathy,history of foot ulcers,vascular atheroma;cardiac,PAOD -VX neck,HbA1c,fructosamine,nb of hypoglycemic episodes,TIR,TBR,TAR,CV(overall & for each meal);GMI,GRI,blood glucose at start of emptying, 3-day weekly analysis, GCSI score, Number of AE and SAE, Number of times treatment/placebo taken (calculated from number of capsules returned by patient), Ratio of time spent in target range (70-180 mg/dl) over 14 days per subject (in hours)

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