Effectiveness of an oral diabetes-specific supplement on nutritional status, metabolic control, quality or life, and...

The purpose of this study was to assess nutritional status, quality of life (QoL) and function in malnourished or at risk for malnutrition community-dwelling (CD) and nursing home-dwelling (NHD) elderly patients with type 2 diabetes mellitus (DM2), receiving treatment with a diabetes-specific oral nutritional supplement (DSONS).

A prospective, multicentre, observational study was conducted. A DSONS (high-calorie, high-protein, with slow-digestible carbohydrate and high monounsaturated fatty acid - MUFA-content - Glucerna^® 1.5 Cal) had been prescribed the week before inclusion. The following assessments were undertaken at baseline (BL), at week 6 (V1) and at month 3 (FV): body mass index (BMI), glycosylated haemoglobin (HbA_1c), nutritional status (Mini Nutritional Assessment - MNA), QoL (EQ-5D questionnaire), and functional status (Katz Index - KI of Independence in Activities of Daily Living). The data were reported in the overall population (OP) and in the CD and NHD groups.

A total of 402 patients aged 80.8 ± 8.5 years were evaluable (44.5% men), including 61.7% CD and 38.3% NHD. BMI (kg/m²) increased in the OP from 22.0 ± 3.5 at BL to 22.5 ± 3.6 at V1 (p < 0.001) and 23.0 ± 3.7 at the FV (p < 0.001). BMI also increased in the CD group (p < 0.001) and in the NHD group (p < 0.001). HbA_1c decreased in the OP from 7.3 ± 1.1% at BL to 7.2 ± 1.0% at V1 and 7.0 ± 0.9% at the FV (p < 0.001), in both the CD (p < 0.001) and the NHD groups (p = 0.020). The mean overall MNA score increased in the OP from 13.1 ± 4.8 at BL to 17.0 ± 4.7 at V1 and 18.6 ± 5.1 at the FV (p < 0.001). The mean overall MNA score also increased in the CD (p < 0.001) and the NHD groups (p < 0.001). The mean overall EQ-5D score improved in the OP from 46.0 ± 18.0 at BL to 54.8 ± 17.5 at V1 and 59.7 ± 18.8 at the FV (p < 0.001). The mean overall EQ-5D score also improved in the CD (p < 0.001) and the NHD groups (p < 0.001). Gastrointestinal adverse events were seen in only 2% of patients. Treatment compliance was 94.4%.

In this study, conducted in routine, multicentre, clinical settings, the treatment with the high-calorie, high-protein, with slow-digestible carbohydrate, and high MUFA content DSNOS - Glucerna^® 1.5 Cal-, was associated with improvements in HbA_1c, nutritional status, BMI and QoL following 6 weeks and 3 months of treatment in both institutionalised and non-institutionalised elderly patients with diabetes who were malnourished or at risk for malnutrition. A slight improvement in functional status was also observed at 12 weeks. As this is an observational effectiveness study, a randomized controlled trial would be necessary to establish a causal relationship between the DSNOS and the described events.