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, MSC, PHARM, CHEM1,
- Antonio Nicolucci, MD1,
- Paolo Di Bartolo, MD2,
- Daniela Bruttomesso, MD3,
- Angela Girelli, MD4,
- Francisco J. Ampudia, MD5,
- David Kerr, MD6,
- Antonio Ceriello, MD7,
- Carmen De La Questa Mayor, MD8,
- Fabio Pellegrini, MSC, STAT1,
- David Horwitz, MD9 and
- Giacomo Vespasiani, MD10
- 1Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro (CH), Italy;
- 2Diabetes Unit, Presidio Ospedaliero, Ravenna, Italy;
- 3Clinical and Experimental Medicine, Policlinico Universitario, Padua, Italy;
- 4Diabetes Unit, Spedali Civili, Brescia, Italy;
- 5Unit of Endocrinology, Hospital Clínico Universitario, Valencia, Spain;
- 6Centre of Postgraduate Medical Research and Education, Bournemouth University, Bournemouth, U.K.;
- 7Warwick Medical School, University of Warwick, Coventry, U.K.;
- 8Unit of Endocrinology, Hospital Universitario Virgen Macarena, Sevilla, Spain;
- 9Medical and Clinical Affairs, LifeScan, Milpitas, California;
- 10Diabetes Unit, Madonna del Soccorso Hospital, San Benedetto del Tronto (AP), Italy.
- Corresponding author: Maria C.E. Rossi, mrossi{at}negrisud.it.
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.
Footnotes
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The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
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- Received July 21, 2009.
- Accepted September 16, 2009.
- © 2010 by the American Diabetes Association.
