PMID- 23340895
OWN - NLM
STAT- MEDLINE
DCOM- 20140203
LR  - 20240413
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Print)
IS  - 0149-5992 (Linking)
VI  - 36
IP  - 7
DP  - 2013 Jul
TI  - Randomized crossover study to examine the necessity of an injection-to-meal 
      interval in patients with type 2 diabetes and human insulin.
PG  - 1865-9
LID - 10.2337/dc12-1694 [doi]
AB  - 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. RESEARCH DESIGN AND 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.
FAU - Muller, Nicolle
AU  - Muller N
AD  - Department of Internal Medicine III, Universitatsklinikum Jena, Jena, Germany. 
      nicolle.mueller@med.uni-jena.de
FAU - Frank, Thomas
AU  - Frank T
FAU - Kloos, Christof
AU  - Kloos C
FAU - Lehmann, Thomas
AU  - Lehmann T
FAU - Wolf, Gunter
AU  - Wolf G
FAU - Muller, Ulrich Alfons
AU  - Muller UA
LA  - eng
SI  - ClinicalTrials.gov/NCT00529165
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130122
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
SB  - IM
MH  - Aged
MH  - Blood Glucose/drug effects
MH  - Cross-Over Studies
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/*administration & dosage/*therapeutic use
MH  - Insulin/*administration & dosage/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Postprandial Period
PMC - PMC3687267
EDAT- 2013/01/24 06:00
MHDA- 2014/02/04 06:00
PMCR- 2014/07/01
CRDT- 2013/01/24 06:00
PHST- 2013/01/24 06:00 [entrez]
PHST- 2013/01/24 06:00 [pubmed]
PHST- 2014/02/04 06:00 [medline]
PHST- 2014/07/01 00:00 [pmc-release]
AID - dc12-1694 [pii]
AID - 1694 [pii]
AID - 10.2337/dc12-1694 [doi]
PST - ppublish
SO  - Diabetes Care. 2013 Jul;36(7):1865-9. doi: 10.2337/dc12-1694. Epub 2013 Jan 22.