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Randomized Controlled Trial Comparative Study Clinical Trial
[A structured treatment and educational program for patients with type 2 diabetes mellitus, insulin therapy and impaired cognitive function (DikoL)].
- Ralf Schiel, Anke Braun, Regina Müller, Christine Helbich, Sabine Siefke, Ines Franke, Brigitte Osterbrink, Karena Leppert, Günter Stein, and Ulrich Alfons Müller.
- Klinik für Innere Medizin III, Friedrich Schiller-Universität, Jena. inselklinik.schiel@medigreif.de
- Med Klin. 2004 Jun 15; 99 (6): 285292285-92.
Background And PurposeMore than 50% of patients with type-2 diabetes mellitus and impaired cognitive function are overtaxed with some topics of established structured treatment and teaching programs for patients with insulin therapy. This leads to substantial deficits in respect of the patients' ability of diabetes self-management (insulin injections, self-monitoring) and the need for help by relatives and social workers. The consequences are an impaired quality of life and a great deal of expense in the welfare system. Since 1996, a specialized structured treatment and teaching program for patients with type-2 diabetes mellitus, insulin therapy, and impaired cognitive function (DikoL) has been developed. Main differences in comparison to established programs were less theoretical topics (no pathophysiology, no insulin action, no complicated calculation of carbohydrate pounds) and more time for practical exercise. In a randomized prospective study, the effectiveness of the DikoL program was evaluated.Patients And MethodsAll patients with type-2 diabetes mellitus (n = 106, age 68.6 +/- 8.7 years, median diabetes duration 10.3 [0.03-35.4] years, HbAlC 10.3+ 1.7% [HPLC, Diamat, normal range 4.5-6.3%], cognitive function 87.7 +12.3 IQ points), admitted to hospital to participate in a structured treatment and teaching program between April 1999 and June 2000, were studied. Patients with impaired cognitive function (< 91 IQ points) were randomized: they participated either in an established structured treatment and teaching program according to Berger et al. (standard group: n = 35) or in the DikoL program(DikoL group: n = 33). Immediately after participation and 0.5 years later, the quality of diabetes control, patients' knowledge of diabetes, their ability for diabetes self-management, and their satisfaction with the program were evaluated.ResultsPatients of the DikoL group had a comparable quality of diabetes control (HbAlc: DikoL vs. standard group: 8.5 + 1.3 vs. 8.3 +/- 1.4%; p = 0.62)and diabetes-related knowledge (DikoL vs. standard group: 9.6 +/- 4.4 vs.10.3 + 3.8 points; p = 0.52), but significantly better results in respect of their ability for diabetes self-management (DikoL vs. standard group: 15.9 +/- 3.1 vs. 12.5 +/- 4.1 points; p = 0.001) than patients of the standard group. Moreover, in the DikoL group there was a tendency to a lower number of patients needing third-party assistance (n = 1 patient of the DikoL group vs. n = 5 patients of the standard group; p = 0.13). There were no acute complications (hypoglycemia, comata, and foot ulcers) in neither group. Following participation in the DikoL program, patients reached a better score in the questionnaire evaluating satisfaction with the treatment and teaching program (DikoL vs. standard group:52.5 + 4.5 vs. 44.7 + 76 points; p < 0,001).ConclusionFollowing the wishes of the majority of diabetes educators as well as diabetologists but also patients' wishes, a specially designed structured treatment and teaching program for patients with type-2 diabetes mellitus, insulin therapy, and impaired cognitive function was designed. DikoL is the first program evaluated in a randomized, prospective trial. It clearly demonstrated a bet-ter outcome for patients with impaired cognitive function in respect of diabetes self-management and satisfaction. With its implementation, patients' quality of diabetes care can be improved in a substantial manner.
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