OBJECTIVETo investigate the effect of flexible intensive insulin therapy (FIIT) and an automated bolus calculator (ABC) in a Danish type 1 diabetes population treated with multiple daily injections. Furthermore, to test the feasibility of teaching FIIT in a 3-h structured course.RESEARCH DESIGN AND METHODSThe BolusCal Study was a 16-week randomized, controlled, open-label, three-arm parallel, clinical study of 51 adults with type 1 diabetes. Patients aged 18–65 years in poor metabolic control (HbA1c 8.0–10.5%) were randomized to the Control (n = 8), CarbCount (n = 21), or CarbCountABC (n = 22) arm. During a 3-h group teaching, the Control arm received FIIT education excluding carbohydrate counting. CarbCount patients were taught FIIT and how to count carbohydrates. CarbCountABC group teaching included FIIT and carbohydrate counting and patients were provided with an ABC.RESULTSAt 16 weeks, the within-group change in HbA1c was −0.1% (95% CI −1.0 to 0.7%; P = 0.730) in the Control arm, −0.8% (−1.3 to −0.3%; P = 0.002) in the CarbCount arm, and −0.7% (−1.0 to −0.4%; P < 0.0001) in the CarbCountABC arm. The difference in change in HbA1c between CarbCount and CarbCountABC was insignificant. Adjusting for baseline HbA1c in a regression model, the relative change in HbA1c was −0.6% (−1.2 to 0.1%; P = 0.082) in CarbCount and −0.8% (−1.4 to −0.1%; P = 0.017) in CarbCountABC. Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (status version) improved in all study arms, but the improvement was significantly greater in CarbCountABC.CONCLUSIONSFIIT and carbohydrate counting were successfully taught in 3 h and improved metabolic control and treatment satisfaction. Concurrent use of an ABC improved treatment satisfaction further.
38Diabetic patients have an increased risk of foot ulcers, and glycation of collagen may increase tissue 39 stiffness. We hypothesized that the level of glycemic control (glycation) may affect Achilles tendon 40 stiffness, which can influence gait pattern. We therefore investigated the relationship between 41 collagen glycation, Achilles tendon stiffness parameters and plantar pressure in poorly (n = 22) and 42 well (n = 22) controlled diabetic patients, including healthy age matched (45-70 yrs) controls (n = 43 11). There were no differences in any of outcome parameters (collagen cross-linking or tendon 44 stiffness) between patients with well-controlled and poorly controlled diabetes. The overall effect of 45 diabetes was explored by collapsing the diabetes groups (DB) compared to the controls. Skin 46 collagen cross-linking lysylpyridinoline (LP), hydroxylysylpyridinoline (HP), (136%, 80%, P < 47 0.01) and pentosidine concentrations (55%, P < 0.05) were markedly greater in DB. Furthermore, 48
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