Diabetes Interactive Diary: a new telemedicine system enabling flexible diet and insulin therapy while improving quality of life: an open-label, international, multicenter, randomized study

Maria C E Rossi, Antonio Nicolucci, Paolo Di Bartolo, Daniela Bruttomesso, Angela Girelli, Francisco J Ampudia, David Kerr, Antonio Ceriello, Carmen De La Questa Mayor, Fabio Pellegrini, David Horwitz, Giacomo Vespasiani, Maria C E Rossi, Antonio Nicolucci, Paolo Di Bartolo, Daniela Bruttomesso, Angela Girelli, Francisco J Ampudia, David Kerr, Antonio Ceriello, Carmen De La Questa Mayor, Fabio Pellegrini, David Horwitz, Giacomo Vespasiani

Abstract

Objective: Widespread use of carbohydrate counting is limited by its complex education. In this study we compared a Diabetes Interactive Diary (DID) with standard carbohydrate counting in terms of metabolic and weight control, time required for education, quality of life, and treatment satisfaction.

Research design and methods: Adults with type 1 diabetes were randomly assigned to DID (group A, n = 67) or standard education (group B, n = 63) and followed for 6 months. A subgroup also completed the SF-36 Health Survey (SF-36) and World Health Organization-Diabetes Treatment Satisfaction Questionnaire (WHO-DTSQ) at each visit.

Results: Of 130 patients (aged 35.7 +/- 9.4 years; diabetes duration 16.5 +/- 10.5 years), 11 dropped out. Time for education was 6 h (range 2-15 h) in group A and 12 h (2.5-25 h) in group B (P = 0.07). A1C reduction was similar in both groups (group A from 8.2 +/- 0.8 to 7.8 +/- 0.8% and group B from 8.4 +/- 0.7 to 7.9 +/- 1.1%; P = 0.68). Nonsignificant differences in favor of group A were documented for fasting blood glucose and body weight. No severe hypoglycemic episode occurred. WHO-DTSQ scores increased significantly more in group A (from 26.7 +/- 4.4 to 30.3 +/- 4.5) than in group B (from 27.5 +/- 4.8 to 28.6 +/- 5.1) (P = 0.04). Role Physical, General Health, Vitality, and Role Emotional SF-36 scores improved significantly more in group A than in group B.

Conclusions: DID is at least as effective as traditional carbohydrate counting education, allowing dietary freedom for a larger proportion of type 1 diabetic patients. DID is safe, requires less time for education, and is associated with lower weight gain. DID significantly improved treatment satisfaction and several quality-of-life dimensions.

Figures

Figure 1
Figure 1
Study flow chart.

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