Up to 60% of individuals with type 2 diabetes (T2DM) do not participate in regular physical activity (PA) despite the known benefits. To encourage these individuals to increase PA behavior, this study tested the feasibility and implementation of a nurse-directed counseling intervention using continuous glucose monitoring system (CGMS). The study used a framework derived from self-efficacy theory to 1) compare changes in self-efficacy, BP and activity counts between participants receiving CGMS counseling and standard T2DM counseling, 2) examine relationships between PA self-efficacy and BP and activity counts, 3) evaluate recruitment, retention, and screening strategies, and 4) assess instrument reliability and utility. Adults (N=52) with T2DM (non-insulin requiring, inactive) were randomized to intervention (n=27) or control groups (n=25). Both groups received 90 minutes of diabetes education with a follow-up phone call at 4 weeks. The intervention group also received feedback on their own CGMS graphs and a role model's graph depicting PA related reductions in glucose levels. PA benefits/barriers were discussed and goals were set. Outcomes were recorded at 1 and 8 weeks. Participants were older (57±14 years), predominantly (90%) white, about half (52%) female, and had diabetes for 8±7 years. Relative to the control group, participants receiving the intervention had higher self-efficacy scores at 8 weeks, indicating more confidence in sticking to a PA program. Their light/sedentary activity minutes decreased significantly and moderate activity minutes increased significantly; systolic BP, A1c and BMI decreased significantly. Only self-efficacy for "Sticking to it" was positively associated with moderate activity. The most successful recruitment media was multiple newspaper press releases. Most referrals came from endocrinology physicians. Of 231 study volunteers, 106 did not meet the criterion of A1c≥7.5%. These data suggest that CGMS feedback is feasible for counseling individuals with T2DM to improve PA and may improve risk factors for diabetes-related complications. Newspaper press releases are effective for recruiting participants with T2DM. Less restrictive inclusion criteria in a larger study may allow more participation by sedentary individuals with T2DM but may reduce effect size. CGMS was well tolerated and its data aided diabetes-related teaching.

BACKGROUND: The prevalence of type 2 diabetes and diabetes-related morbidity and mortality is higher among low-income Hispanics when compared to that of Whites. However, little is known about how to effectively promote self-management in this population. PURPOSE: The objectives were first to determine the feasibility of conducting a randomized clinical trial of an innovative self-management intervention to improve metabolic control in low-income Spanish-speaking individuals with type 2 diabetes and second to obtain preliminary data of possible intervention effects. METHODS: Participants for this pilot study were recruited from a community health center, an elder program, and a community-wide database developed by the community health center, in collaboration with other agencies serving the community, by surveying households in the entire community. Participants were randomly assigned to an intervention (n = 15) or a control (n = 10) condition. Assessments were conducted at baseline and at 3 months and 6 months postrandomization. The intervention consisted of 10 group sessions that targeted diabetes knowledge, attitudes, and self-management skills through culturally specific and literacy-sensitive strategies. The intervention used a cognitive-behavioral theoretical framework. RESULTS: Recruitment rates at the community health center, elder program, and community registry were 48%, 69%, and 8%, respectively. Completion rates for baseline, 3-month, and 6-month assessments were 100%, 92%, and 92%, respectively. Each intervention participant attended an average of 7.8 out of 10 sessions, and as a group the participants showed high adherence to intervention activities (93% turned in daily logs, and 80% self-monitored glucose levels at least daily). There was an overall Group x Time interaction (p = .02) indicating group differences in glycosylated hemoglobin over time. The estimated glycosylated hemoglobin decrease at 3 months for the intervention group was -0.8% (95% confidence intervals = -1.1%, -0.5%) compared with the change in the control group (p = .02). At 6 months, the decrease in the intervention group remained significant, -0.85% (95% confidence intervals = -1.2, -0.5), and the decrease was still significantly different from that of the controls (p = .005). There was a trend toward increased physical activity in the intervention group as compared to that of the control group (p = .11) and some evidence (nonsignificant) of an increase in blood glucose self-monitoring in the intervention participants but not the control participants. Adjusting for baseline depressive scores, we observed a significant difference in depressive symptoms between intervention participants and control participants at the 3-month assessment (p = .02). CONCLUSIONS: Low-income Spanish-speaking Hispanics are receptive to participate in diabetes-related research. This study shows that the pilot-tested diabetes self-management program is promising and warrants the conduct of a randomized clinical trial.

OBJECTIVE: This study compared glycemic control in finger tip versus forearm sampling methods of self-monitoring of blood glucose (SMBG). RESEARCH DESIGN AND METHODS: One hundred seventy-four insulin-using patients with type 2 diabetes were randomized to SMBG using either finger-tip testing (FT) or forearm alternative site testing (AST) and followed up for 7 months. Hemoglobin A1C (HbA1C) was measured at baseline, month 4, and month 7. The study was designed to test the noninferiority of the AST method for the primary end point of change in HbA1C from baseline to month 7. Adherence with the testing schedule and frequency of hypoglycemic episodes were also measured. RESULTS: The FT (n = 85) and AST (n = 89) groups each had significant decreases in mean HbA1C from baseline to month 7 (FT, -0.4 +/- 1.4%, P = 0.008; AST, -0.3 +/- 1.2%, P = 0.045), and noninferiority between groups was demonstrated with a margin of equivalence of 0.5 (P = 0.043). There was no observable difference in HbA1C change between the groups (P = 0.442). Adherence was better in the FT (87%) than the AST (78%) group (P = 0.003), which may have been because of the difficulty some subjects had in obtaining blood samples for AST. The number of hypoglycemic episodes was too small to assess for a difference between groups. CONCLUSIONS: SMBG by the AST, rather than FT, method did not have a detrimental effect on long-term glycemic control in insulin-using patients with type 2 diabetes. Although adherence with testing was expected to be better in the AST group, it was actually better in the FT group.