Patients living with type 1 diabetes (PwT1D) still have trouble controlling their blood sugar, even with the latest treatments. PwT1D may have slow stomach emptying influencing blood glucose level. Treating this is an important goal. A recent study found that 30% of PwT1D had a slower gastric emptying rate, even though they had no other complications and were not experiencing any digestive issues. Slowing of gastric emptying is linked to gastric hypoglycaemia, which is a life-threatening condition that can affect quality of life, and to higher blood sugar level after eating. This can last throughout the night. Prokinetic treatments for the stomach are good for diabetic patients with slow digestion. These treatments help with stomach pain and, to a lesser extent, with hypoglycemia. However, there is no data on the benefits of such treatments in patients with no digestive symptoms, on glycaemic control as defined by continuous glucose monitoring data. In fact, this may be more relevant than HbA1c in patients with alternating hypo- and/or hyperglycaemia. The investigator thinks that a prokinetic agent like domperidone could improve glycaemic control in PwT1D with slow gastric emptying and glycaemic imbalance. This study tests how domperidone affects blood sugar levels in PwT1D. Patients will be administrated domperidone or a placebo for 28 days. The investigator will see how long T1D patients spend within their blood sugar target range over 14 days using a continuous glucose monitor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
30 mg per day for 21 days
3 per day for 21 days
gastric emptying test
CHU Amiens
Amiens, France
CHU de CAEN
Caen, France
CH Dieppe
Dieppe, France
Centre Hospitalier Intercommunal Elbeuf, Louviers, Val de Reuil
Elbeuf, France
GH Le Havre
Le Havre, France
CHU de ROUEN
Rouen, France
Percentages of time spent within the TIR (Time In Range) glycemic target range (70-180 mg/dL)
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
Time frame: 14 days after domperidone or placebo
Variation in glycemic control criteria : HbA1c assay
Variation in HbA1c assay between domperidone and placebo (measurement of differences)
Time frame: 14 days after domperidone of placebo
Variation in glycemic control criteria : Plasma fructosamine assay
Variation in Plasma fructosamine assay between domperidone and placebo (measurement of differences)
Time frame: 14 days after domperidone of placebo
Variation in glycemic control criteria : Insulin dose
Variation in Insulin dose between domperidone and placebo (measurement of differences)
Time frame: 14 days after domperidone of placebo
Safety Outcome : AE and SAE Occurrence
Number of AE and SAE
Time frame: 105 days
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