| Title | A(1c) control in a primary care setting: self-titrating an insulin analog pre-mix (INITIATEplus trial). | | Author(s) | Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Trippe BS, INITIATEplus Study Group | | Institution | Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. d-oyer@northwestern.edu | | Source | Am J Med 2009 Nov; 122(11):1043-9. | | MeSH | Blood Glucose
Blood Glucose Self-Monitoring
Diabetes Mellitus, Type 2
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Follow-Up Studies
Hemoglobin A, Glycosylated
Humans
Hypoglycemia
Hypoglycemic Agents
Insulin
Male
Middle Aged
Primary Health Care
Treatment Outcome
| | Abstract | PURPOSE: To study glycemic control and hypoglycemia development upon initiation of insulin through a self-titration schedule in a 24-week trial, conducted with 4875 insulin-naïve patients with poorly controlled type 2 diabetes, predominantly in a primary care setting.
METHODS: Subjects initiated twice-daily biphasic insulin aspart 70/30 with 6 units prebreakfast and 6 units presupper, self-titrating according to self-measured blood glucose values. Subjects were randomized (1:1:1) to telephone counseling provided by a registered dietician: no counseling (NC), 1 counseling session (1C), or 3 sessions (3C).
RESULTS: Mean baseline HbA(1c) (9.9% across groups) decreased approximately 2.5% to 7.49% + or - 1.48, 7.48% + or - 1.50, and 7.44% + or - 1.46 in the NC, 1C, and 3C groups, respectively. Within these groups, a hemoglobin A(1c) (HbA(1c)) value <7% was achieved by 40.2%, 41.6%, and 41.8% of subjects, respectively. Eight-point blood glucose profiles were substantially improved from baseline for all groups. Hypoglycemia was experienced by 10.2%-11.4% of the subjects in each group. Rates of minor and major hypoglycemia were low but decreased as dietary counseling increased (minor hypoglycemia: 56 vs 50 vs 45 episodes per 100 patient-years; major hypoglycemia, 9 vs 6 vs 4 episodes per 100 patient-years, for the NC vs 1C vs 3C groups, respectively; P <.001, 3C vs NC). Weight increased by 3.13, 3.40, and 2.88 kg for the NC, 1C, and 3C groups, respectively.
CONCLUSION: In the primary care setting, self-titration of biphasic insulin aspart 70/30 was effective in achieving recommended HbA(1c) goals even with minimal dietary counseling. | | Language | eng | | Pub Type(s) | Clinical Trial, Phase IV
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
| | PubMed ID | 19854333 |
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