Effectiveness of an oral diabetes-specific supplement on nutritional status, metabolic control, quality or life, and functional status in elderly patients. A multicentre study

Background & aims 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). Methods 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 (HbA1c), 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. Results 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). HbA1c 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%. Conclusions 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 HbA1c, 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.