title: Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin.
abstract: OBJECTIVE
  Patients with diabetes and insulin therapy with human insulin were usually instructed to use an interval of 20-30 min between the injection and meal. We examined the necessity of the injection-to-meal interval (IMI) in patients with type 2 diabetes mellitus (T2DM) and flexible insulin therapy with human insulin.
  
  
  METHODS
  In this randomized, open crossover trial, 100 patients with T2DM (47% men, mean age = 66.7 years) were randomized to the IMI first group (phase 1, IMI 20 min; phase 2, no IMI) or IMI last group (phase 1, no IMI; phase 2, IMI 20 min). The main outcome measures were HbA1c, blood glucose profile, incidence of hypoglycemia, quality of life, treatment satisfaction, and patient preference.
  
  
  RESULTS
  Forty-nine patients were randomized to the IMI first group and 51 patients to the IMI last group. Omitting the IMI only slightly increases HbA1c (average intraindividual difference = 0.08% [95% CI 0.01-0.15]). Since the difference is not clinically relevant, a therapy without IMI is noninferior to its application (P < 0.001). In the secondary outcomes, the incidence of mild hypoglycemia also did not differ between no IMI and IMI significantly (mean of differences = -0.10, P = 0.493). No difference in the blood glucose profile of both groups was found. Treatment satisfaction increased markedly, by 8.08, if IMI was omitted (P < 0.001). The total score of the quality of life measure did not show differences between applying an IMI or not. Insulin therapy without IMI was preferred by 86.5% of patients (P < 0.001).
  
  
  CONCLUSIONS
  An IMI for patients with T2DM and preprandial insulin therapy is not necessary.
authors: Department of Internal Medicine III, Universitätsklinikum Jena, Jena, Germany. nicolle.mueller@med.uni-jena.de
authors: Nicolle
authors: N
authors: Müller
authors: Thomas
authors: T
authors: Frank
authors: Christof
authors: C
authors: Kloos
authors: Thomas
authors: T
authors: Lehmann
authors: Gunter
authors: G
authors: Wolf
authors: Ulrich Alfons
authors: UA
authors: Müller
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019518:Postprandial Period
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin