Abstract
Background:
Post-meal hyperglycemia is emerging as a cardiovascular risk factor and may be elevated despite a hemoglobin A1C (A1C) of <7%. The Simple Start™ DVD (LifeScan, Milpitas, CA) was developed to educate patients about glycemic targets and dietary changes that could lessen glycemic excursions. We evaluated SimpleStart in a controlled, randomized, prospective trial using continuous glucose monitoring (CGM).
Methods:
Thirty subjects with type 2 diabetes mellitus having an A1C of <7.0% (mean 6.0%) were recruited from the Center's population. Subjects were randomized to either Simple Start DVD presentation and a 30-min diet education course (SS Group) or just the latter (Control Group). Subjects were seen at baseline and during weeks 6 and 12 by an investigator. Life-style and medication changes were advised based on history and self-monitored blood glucose down-loaded meter data. CGM and A1C were done at baseline and during weeks 6 and 12.
Results:
Twenty-eight subjects completed the 12-week study with 14 subjects in the SS Group and Control Group being compared. There was no significant difference in the baseline or subsequent A1C levels or overall CGM glucose values between groups or over time. SMBG frequency was significantly increased in the SS Group from <1.0 per day to 2.0 per day (P < 0.001). At week 12, the mean glucose for the 4-h after-meal period was significantly lower in the SS Group than in the Control Group at breakfast and lunch in those subjects with adequate CGM tracings (P < 0.05).
Conclusion:
An educational program incorporating Simple Start facilitates patient behavioral changes, decreasing post-meal hyperglycemia.
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