Fast-Acting Insulins and Their Post-Meal Effects in Type 1 Diabetes
Key facts
- Where
- Bochum, NémetországSee the site
- Phase
- 1. fázis
Where in Németország
- Katholisches Klinikum Bochum gGmbHBochum, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Katholisches Klinikum Bochum gGmbH
- Trial code
- EU 2023-509217-37-00
- Record updated
- 2025. szeptember 17.
- Original description
The primary objective of the study is to optimize postprandial blood glucose profiles (avoiding excessive hyperglycemia and its consequences on accompanying oxidative stress reactions) by considering the velocity of gastric emptying through the selection of the most suitable rapid-acting mealtime insulin.Read full original descriptionShow less
Influence of various fast-acting mealtime insulin preparations in individuals with type 1 diabetes, with slow, moderate, and rapid gastric emptying, on postprandial blood glucose and the formation of reactive oxygen species
The primary objective of the study is to optimize postprandial blood glucose profiles (avoiding excessive hyperglycemia and its consequences on accompanying oxidative stress reactions) by considering the velocity of gastric emptying through the selection of the most suitable rapid-acting mealtime insulin.
Inclusion: Diabetes mellitus type 1; HbA1c ≥ 6.0% [42 mmol/l] and ≤ 8.0% [64 mmol/l]; Generally good overall health; Age ≥ 18 and ≤ 80 years; Body mass index (BMI) ≥ 18.5 and ≤ 35 kg/m².
Exclusion: Blood donation within the past 12 weeks prior to the study; Conventional insulin therapy; Recurrent or severe hypoglycemia within the past four weeks before study enrollment, indicating a need for therapy optimization; Use of medication within 2 weeks before the study or ongoing use of medications that could affect gastrointestinal motility, body weight, or appetite; Other types of diabetes (e.g., type 2 diabetes) or unspecified diabetes mellitus; Indications of a severe illness that could impact participation in the study or the results (e.g., epilepsy, cardiovascular disease, pulmonary disease, active cancer); Allergies or intolerances that could hinder the study's execution; Positive medical history of gastrointestinal diseases, especially symptomatic upper or lower gastrointestinal tract disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease, pancreatitis, gastric conditions like gastroparesis); History of gastrointestinal surgery (except uncomplicated cholecystectomy or appendectomy); Inadequate metabolic control (HbA1c < 6.0% [42 mmol/l] or > 8.0% [64 mmol/l]); Chronic kidney insufficiency (eGFR < 30 ml/min according to CKD-EPI formula); Chronic liver disease (transaminases > 2 times the upper normal limit); Anemia (Hb < 11.5 mg/dl in women or < 13.5 mg/dl in men); Pregnancy; Clinically relevant thyroid dysfunction (hypo- and hyperthyroidism) without stable treatment; Substance abuse (including alcohol consumption of more than 20g of alcohol or more than 10 cigarettes per day); Participation in other medical studies within the past three months; Inability to provide informed consent; Unwillingness to consume the test meal (e.g., refusal to eat chicken eggs); Proliferative retinopathy.