Diabetes Interactive Diary: A New Telemedicine System Enabling Flexible Diet and Insulin Therapy While Improving Quality of Life

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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.

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Most cited references 14

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The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups.

C A McHorney, J E Ware, J Lu … (1994)

The widespread use of standardized health surveys is predicated on the largely untested assumption that scales constructed from those surveys will satisfy minimum psychometric requirements across diverse population groups. Data from the Medical Outcomes Study (MOS) were used to evaluate data completeness and quality, test scaling assumptions, and estimate internal-consistency reliability for the eight scales constructed from the MOS SF-36 Health Survey. Analyses were conducted among 3,445 patients and were replicated across 24 subgroups differing in sociodemographic characteristics, diagnosis, and disease severity. For each scale, item-completion rates were high across all groups (88% to 95%), but tended to be somewhat lower among the elderly, those with less than a high school education, and those in poverty. On average, surveys were complete enough to compute scales scores for more than 96% of the sample. Across patient groups, all scales passed tests for item-internal consistency (97% passed) and item-discriminant validity (92% passed). Reliability coefficients ranged from a low of 0.65 to a high of 0.94 across scales (median = 0.85) and varied somewhat across patient subgroups. Floor effects were negligible except for the two role disability scales. Noteworthy ceiling effects were observed for both role disability scales and the social functioning scale. These findings support the use of the SF-36 survey across the diverse populations studied and identify population groups in which use of standardized health status measures may or may not be problematic.

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The Italian SF-36 Health Survey: translation, validation and norming.

G Apolone, P. Mosconi (1998)

This article reports on the development and validation of the Italian SF-36 Health Survey using data from seven studies in which an Italian version of the SF-36 was administered to more than 7000 subjects between 1991 and 1995. Empirical findings from a wide array of studies and diseases indicate that the performance of the questionnaire improved as the Italian translation was revised and that it met the standards suggested by the literature in terms of feasibility, psychometric tests, and interpretability. This generally satisfactory picture strengthens the idea that the Italian SF-36 is as valid and reliable as the original instrument and applicable and valid across age, gender, and disease. Empirical evidence from a cross-sectional survey carried out to norm the final version in a representative sample of 2031 individuals confirms the questionnaire's characteristics in terms of hypothesized constructs and psychometric behavior and gives a better picture of its external validity (i.e., robustness and generalizability) when administered in settings that are very close to real world.

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Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial.

(2002)

To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes. Randomised design with participants either attending training immediately (immediate DAFNE) or acting as waiting list controls and attending "delayed DAFNE" training 6 months later. Secondary care diabetes clinics in three English health districts. 169 adults with type 1 diabetes and moderate or poor glycaemic control. Glycated haemoglobin (HbA(1c)), severe hypoglycaemia, impact of diabetes on quality of life (ADDQoL). At 6 months, HbA(1c) was significantly better in immediate DAFNE patients (mean 8.4%) than in delayed DAFNE patients (9.4%) (t=6.1, P<0.0001). The impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients (t=-5.4, P<0.0001), as was the impact of diabetes on overall quality of life (t=2.9, P<0.01). General wellbeing and treatment satisfaction were also significantly improved, but severe hypoglycaemia, weight, and lipids remained unchanged. Improvements in "present quality of life" did not reach significance at 6 months but were significant by 1 year. Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk. This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation.

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Author and article information

Journal

Journal ID (nlm-ta): Diabetes Care

Journal ID (hwp): diacare

Journal ID (pmc): dcare

Journal ID (publisher-id): Diabetes Care

Title: Diabetes Care

Publisher: American Diabetes Association

ISSN (Print): 0149-5992

ISSN (Electronic): 1935-5548

Publication date (Print): January 2010

Publication date (Electronic): 6 October 2009

Volume: 33

Issue: 1

Pages: 109-115

Affiliations

[1] ¹Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro (CH), Italy;

[2] ²Diabetes Unit, Presidio Ospedaliero, Ravenna, Italy;

[3] ³Clinical and Experimental Medicine, Policlinico Universitario, Padua, Italy;

[4] ⁴Diabetes Unit, Spedali Civili, Brescia, Italy;

[5] ⁵Unit of Endocrinology, Hospital Clínico Universitario, Valencia, Spain;

[6] ⁶Centre of Postgraduate Medical Research and Education, Bournemouth University, Bournemouth, U.K.;

[7] ⁷Warwick Medical School, University of Warwick, Coventry, U.K.;

[8] ⁸Unit of Endocrinology, Hospital Universitario Virgen Macarena, Sevilla, Spain;

[9] ⁹Medical and Clinical Affairs, LifeScan, Milpitas, California;

[10] ¹⁰Diabetes Unit, Madonna del Soccorso Hospital, San Benedetto del Tronto (AP), Italy.

Author notes

Corresponding author: Maria C.E. Rossi, mrossi@ 123456negrisud.it .

Article

Publisher ID: 1327

DOI: 10.2337/dc09-1327

PMC ID: 2797954

PubMed ID: 19808926

SO-VID: 9b38fbf1-effe-433e-b973-4528b6abf3ce

License:

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

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

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Abstract

OBJECTIVE

RESEARCH DESIGN AND METHODS

RESULTS

CONCLUSIONS

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GLUT4 biology

Most cited references 14

The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups.

The Italian SF-36 Health Survey: translation, validation and norming.

Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial.

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