Diabetes is a disease that is no longer uncommon. To understand the possible treatments of the disease, and what results that new ways of treatment can bring, this paper aims to analyze the findings after a clinical trial to maintain glycemic control with different treatments. Although the results showed that the best treatment included a combination of metformin and rosiglitazone, it is not yet possible to determine whether this treatment would be safe for both adolescents and adults. The following topics are discussed in this essay: protection of human participants, data collection, data management and analysis, findings and interpretation of findings, and implications for practice and future research.
Protection of Human Participants
No matter how simple the research may be, there are always risks and benefits that one should consider. The research states that “three study-specific serious adverse events were tracked: severe hypoglycemia, diabetic ketoacidosis, and lactic acidosis” (“TODAY Study Group,” 2012, p. 2249). Different methods of treatment can help the participants maintain the durability of glycerin control because rosiglitazone and metformin together helped to avoid treatment failure, while metformin monotherapy showed no such results (“TODAY Study Group,” 2012, p. 2254). The authors (2012) note that the lifestyle program (plus the pharmaceutical treatment) has also influenced the percentage of excess weight among the participants (p. 2254). It has not, however, changed or prolonged the durability of the glycerin control; this could also be considered as a risk for the participants. Both the parents and their children provided their consent and the study protocol was approved by the institutional review board, as the authors claim (“TODAY Study Group,” 2012, p. 2249). The trial was safe for the participants, and there were no violations.
The collected data helps in the understanding of the results. The major variables included independent (metformin-only treatment, metformin combined with rosiglitazone, or a lifestyle-intervention program) and dependent (glycemic control) variables. The data coordinating centers collected the data, and a plan developed by the biostatisticians was also used (“TODAY Study Group,” 2012, p. 2249). Although the authors do not provide the rationale for using this method, one might assume that the data, as collected and proved by different investigators, had a higher level of accuracy. The treatment’s duration was different, from two to six years, starting in July 2004 and ending in February 2009 (“TODAY Study Group,” 2012, p. 2256). The data was collected when the participants came for a follow-up, and at scheduled visits with the investigators (“TODAY Study Group,” 2012, p. 2248). To conclude, the data was collected with the help of both investigators and participants.
Data Management and Analysis
Data management and analysis in this study were thorough. Participants who did not withdraw from the treatment and experienced no treatment failure were examined according to the treatment groups they were in: “The trial was powered for the three pairwise comparisons among treatment groups for the primary outcome, each at a significance level of 0.0167” (“TODAY Study Group,” 2012, p. 2249). To measure the changes between the groups, general linear mixed models were used, while “For secondary outcomes and analyses, a P value of 0.05 was considered to indicate statistical significance, with no adjustment for multiple testing” (“TODAY Study Group,” 2012, p. 2249). The software used to assure the accuracy was “PROC LIFEREG, SAS software, version 9.2, SAS Institute” (“TODAY Study Group,” 2012, p. 2249). To minimize the effects of researcher bias, none of the participants or managers of the trial, including the study personnel, received any information about the assignments to any medicine used (“TODAY Study Group,” 2012, p. 2246). These methods allow assuming the results were veridical.
Findings / Interpretation of Findings: Implications for Practice and Future Research
A coherent interpretation of findings is an important part of any research. The researchers point out that the metformin monotherapy sustained a durable glycemic control only in half of the participants. In contrast, a combination of metformin and rosiglitazone increased the duration of the glycemic control, and metformin plus lifestyle intervention showed the same results as the metformin alone (“TODAY Study Group,” 2012, p. 2253). The findings appear to be valid, but, as the researchers stress, the durability of glycemic control in adolescents was lower than in adults, and these results should be analyzed to understand if they depend on biological or pathophysiological differences (“TODAY Study Group,” 2012, p. 2254). Due to the limited sample size and skeletal growth of the participants, the effects of rosiglitazone on bone density should be interpreted with caution (“TODAY Study Group,” 2012, p. 2254). Some facts helpful to the nursing practice were provided: The combination of metformin and rosiglitazone showed better treatment results in female participants, and metformin alone was not as effective in non-Hispanic black participants as in other ethnic groups (“TODAY Study Group,” 2012, p. 2254). The study provides further possibilities for researchers to improve or revise the results.
The study provided is important proof that there are several new ways to treat diabetes; nevertheless, the results show that the side-effects must be examined more closely, and the reason for the treatment failure in different groups must be determined. The best results were shown in the groups treated with metformin and rosiglitazone. The results of the study suggest that practicing nurses should consider combining metformin treatment and other approaches, including lifestyle programs. Lifestyle programs do not improve glycerin control but contribute to weight loss for the participants. The ethnic group of the participants also influenced the outcome.
TODAY Study Group. (2012). A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med, 2012(366), 2247-2256.