Document for Quality Improvement Project

Using continuous glucose monitoring to monitor blood glucose in adult patients with type II diabetes

Theoretical Foundation

Literature Synthesis

Practice Change Recommendation

List the primary points for six sections

i. Background of the practice problem/gap at the project site

Several chronic conditions negatively impact the lives of patients. Among such conditions is diabetes. Diabetes causes numerous other complications, such as kidney disease, heart disease, and stroke (Skinner et al., 2020). The other concern about diabetes is that it affects millions of people, making them unable to live normal lives. The implication is that various researchers and stakeholders have, in the past and present, been pursuing effective ways or strategies to better manage diabetes. Non-the less, diabetes is still among the most prevalent chronic conditions (Khan et al., 2019). According to Khan et al. (2019) the diabetes global prevalence among the adult population is as high as 9%. The interventions currently in use among patients living with diabetes majorly focus on helping patients attain better healthcare outcomes, such as better glycemic control and keeping in check the risky lifestyle behaviors that may hinder the control and management of the condition (Maiorino et al., 2020). Even though effective interventions should be applied, the management strategies used in the practice site have not achieved the desired results as most of the patients fail to achieve the required HbA1c levels. Indeed, uncontrolled levels of HbA1c have been connected to myocardial infarction and stroke disease (Azhar et al., 2022). It hurts to use an invasive glucometer. The discomfort is the same even if the needle is very small. Some individuals may be able to adjust to it and tolerate it, but for others, it may be too much to handle, leading to the issue of non-compliance. The patient’s ability to regulate their blood sugar may suffer as a result, leading to bouts of hyperglycemia and hypoglycemia The risk of diabetic complications is increased by noncompliance, making it a potentially life-threatening issue, hence the need to have a different way to measure glucose more effectively and non-invasively.

ii. Significance of the practice problem/gap at the project site

As earlier highlighted, diabetes causes other undesirable problems apart from making those who live with it spend more money on treatment and management (Bommer et al., 2018). Therefore, the need to control and manage the disease has attracted the attention of several stakeholders, including nurses, doctors, and other researchers in the medical and nursing fields. There have been advancements in the management of diabetes, largely due to the new innovative technologies used in diagnostics and treatment (Haque et al., 2021). However, the annual number of people who get the disease still runs into millions. In addition, the prevalence rates have been rising in recent years, while several others die annually due to diabetes (Khan et al., 2019). The negative impacts caused by the disease can reduce through using nursing interventions based on the current technology and technological applications such as continuous glucose monitoring. The intervention can dictate the rate of practitioners ordering Continuous glucose monitoring as directed by the results to further improve outcomes. The implication is that, in the event that continuous glucose monitoring leads to improvement in the expected HbA1c levels, then the practitioners at the project site are more likely to increase the rates of the ordering of continuous glucose monitoring for better outcomes (Root et al., 2022). Modern intensive diabetic care relies on regular and precise monitoring of blood glucose levels. This used to require many time-consuming and uncomfortable daily random blood glucose readings, which served as a substantial deterrent to reaching intended blood glucose targets. Self-monitoring blood glucose (SMBG) simply gives you a single reading of the blood sugar level and doesn’t tell user anything about the trend or pace of the sugar levels even if used consistently. This means that most individuals, notwithstanding the checking their glucose concentration multiple times a day, nonetheless fail to meet their goals. CGM is a major improvement because it offers immediate evaluation on the efficacy of diabetic therapies (such insulin delivery), and it gives alerts when serum sugar levels reach critically excessive or inadequate. more importantly, it offers real-time glucose reading at regular intervals. This is significant to the research, since benefits of CGM out do the shortcomings, which include high cost.

iii. Theoretical Foundations (choose one nursing theory and one evidence-based change model to be the foundation for the project):

Nursing theories are key in implementing nursing interventions as they offer a framework upon which to base the aspects of interventions (Brandão et al., 2019). Therefore, this project will use Dorothea Orem’s self-care theory. The theory is mainly defined as the act of helping others by offering and maintaining self-care to maintain and improve human functioning at the home level effectiveness. The theory states that an individual has an ability to perform self-care as “the practice of activities that individuals initiate and perform on their behalf to maintain life, health, and well-being (Butts & Rich, 2018). Dorothea’s theory has three interconnected sub-theories; the theory of self-care, the self-care deficit theory, and the theory of nursing systems (Orem & Calnan, 1972). Dorothea Orem’s theory is one of the nursing theories widely applied in nursing quality improvement and change initiatives. This theory will be used in guiding the DNP project on diabetes management and prevention. Self-care is key in diabetes management. Therefore, the underpinnings will be key in helping the individuals evaluate themselves and choose the necessary actions required to attend to the needs of self-care by accomplishing the actions (Butts & Rich, 2018), which in this case is continuous glucose monitoring. Therefore, patients can be motivated to follow the interventions for better care. The theory underlines that self-care is learned and is more natural to adults. Therefore, it will guide the project toward promoting self-care for healthcare, well-being, and self-maintenance among the identified patients living with diabetes.

The theory is also appropriate for the management of diabetes as it also focuses on the possible deficits that the caregivers or the patients may be having in terms of appropriate resources and information key to better management (Orem & Calnan, 1972). In addition, the theory also highlights the inability of patients to take care of themselves, hence the need for support. The patients will, therefore, be able to lower the chances of emergency room visits by taking instructions on the use of continuous glucose monitoring. The use of continuous glucose monitoring also focuses on self-care as the patients will be required to use the monitors, and the existence of a deficit will be a springboard to help the caregivers to collaborate and offer the best to achieve the set goals. Another aspect of the theory is the application of innovative and creative ideas (Orem & Calnan, 1972). Such ideas are key if the evidence is to be used to positively impact patient outcomes. As such, upon the improvement of patient outcomes through glucose monitoring, the impact and the next set of goals will be communicated to the care teams to help facilitate the new practice with the major focus of improving patient outcomes.

Lewin’s change theory will provide the theoretical foundation and constructs in the change practice by addressing behaviors, fears, anxieties, and attitudes and reducing stakeholder worries. Kurt Lewin’s change theory comprises three stages, unfreezing, change, and refreezing (Lewin, 1947); (Hussain et al., 2018). The theory asserts that there are two types of forces, the driving and restraining forces pushing in the direction that makes change happen and the direction that hinders the change, respectively (Lewin, 1947). A change only occurs when the driving forces override the restraining forces (Cummings et al., 2016). In the unfreezing stage, a method is proposed to help individuals move from old behavior patterns and accept change. The change or moving stage entails changing behavior, feeling, and thoughts. The final step, refreezing, entails making the new change as a new habit or standard (Lewin, 1947). When applying the change model, the unfreezing stage will involve asserting the need for patients to have improved HbA1c levels hence the need for more effective intervention. During this stage, the nurses involved will ensure that the patients see the urgency of the need to have well-controlled HbA1c levels. The second step will involve implementing the proposed intervention to reduce HbA1c levels in diabetic patients. Support is offered to nurses who offer the intervention to patients, and the patients are encouraged to adhere to the intervention requirements. At this stage, the intervention is rolled out, and the patients are encouraged to use continuous glucose monitoring. The final step will involve making the intervention part of standard practice to ensure that patients have better outcomes. Therefore, nurses will be advised to apply the intervention to patients with diabetes for better diabetes outcomes. Besides, ordering continuous glucose monitoring by the practitioners will be expected to be the standard part of the diabetes management practices at the facility.

iv. Annotated bibliography.

Beck, R. W., Riddlesworth, T. D., Ruedy, K., Ahmann, A., Haller, S., Kruger, D., … & DIAMOND Study Group. (2017). Continuous glucose monitoring versus usual care in patients with type 2 diabetes receiving multiple daily insulin injections: a randomized trial.  Annals of Internal Medicine,  167(6), 365–374. DOI: 10.7326/M16-2855.

In this study by Beck et al. (2017), the primary aim was to determine the effectiveness of continuous glucose monitoring in adults with type 2 diabetes who were getting insulin injections. By employing a randomized controlled trial as the research design, these researchers recruited one hundred and fifty-eight patients with type 2 diabetes. Seventy-nine patients were randomized into the usual care group, with the remaining half recruited into the intervention group. While the continuous glucose monitoring group used a Dexcom G4 platinum continuous monitoring system to monitor their glucose concentrations, the control groups engaged in glucose self-monitoring. The mean HbA1c levels went down to 7.7 % and 8.0% in the continuous glucose monitoring group and control group, respectively (adjusted difference in mean change, −0.3% [95% CI, −0.5% to 0.0%]; p = 0.022), showing that the intervention was efficacious. When continuous glucose monitoring was performed, there was a statistically significant decrease in HbA1c levels among the patients in the intervention groups. As a result, it suggests that continuous glucose monitoring is essential for enhancing diabetic outcomes like lowered HbA1c levels.

Gilbert, T. R., Noar, A., Blalock, O., & Polonsky, W. H. (2021). Change in hemoglobin A1c and quality of life with real-time continuous glucose monitoring use by people with insulin-treated diabetes in the landmark study.  Diabetes Technology & Therapeutics,  23(S1), S-35. https://doi.org/10.1089/dia.2020.0666

The study by Gilbert et al. (2021) aimed to assess the changes in HbA1c levels upon using a continuous glucose monitoring system. The recruited patients were two hundred and forty-eight, with sixty having Type 2 Diabetes.The participants were requested to upload their point-of-care HbA1c measurements to an online portal. They then used continuous glucose monitoring devices to monitor their HbA1c values and uploaded them to the portal. Upon data analysis, the researchers noted that there was a significant reduction in the levels of HbA1c levels (p-value <0.001). The HbA1c fell significantly from 8.2% (1.9%) at baseline to 7.1% (1.1%) at the end of the study ( p < 0.001); besides, 54 % of those with initial HbA1c values >7% experienced absolute HbA1c reductions of >1%. This study implied that the improved HbA1c levels among the patients are the results of continuous glucose monitoring. Therefore, this study also indicated the importance of continuous glucose monitoring in improving HbA1c and the management of diabetes.

Heinemann, L., Freckmann, G., Ehrmann, D., Faber-Heinemann, G., Guerra, S., Waldenmaier, D., & Hermanns, N. (2018). Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycemia awareness or severe hypoglycemia treated with multiple daily insulin injections (Hypo DE): a multicentre, randomized controlled trial. The Lancet,  391(10128), 1367-1377. https://doi.org/10.1016/S0140-6736(18)30297-6

This study was done by Heinemann et al. (2018). This study’s objective was to determine whether real-time continuous glucose monitoring can effectively reduce the severity and incidences of hypoglycemia. In a six-month randomized controlled study, the researchers randomly assigned 75 individuals to a real-time continuous glucose monitoring group, while 74 were assigned to the control groups. The individuals in the real-time continuous glucose monitoring group were taught how to use the monitoring system. They then used real-time continuous monitoring devices for the period of study. On the other hand, the individuals in the control group used glucometer to self-monitor their blood glucose levels at regular intervals during the day. Upon the analysis of the data, it was noted that the individuals in the intervention group reported a significant reduction in hypoglycemic events (p-value of <0.0001). The mean number of hypoglycemic events per month in the continuous glucose monitoring group was reduced from 10·8 (SD 10·0) to 3·5 (4·7); changes in the control group were not significant (from 14·4 [12·4] to 13·7 [11·6]). Incidence of hypoglycemic events decreased by 72% for participants in the continuous glucose monitoring group (incidence rate ratio 0·28 [95% CI 0·20–0·39], p<0·0001). The study implied that the use of continuous glucose monitoring led to a significant reduction in HbA1c levels hence showing the importance of the intervention in diabetes management and care.

Martens, T., Beck, R. W., Bailey, R., Ruedy, K. J., Calhoun, P., Peters, A. L., … & MOBILE Study Group. (2021). Effect of continuous glucose monitoring on glycemic control in patients with type 2 diabetes treated with basal insulin: a randomized clinical trial.  JAMA,  325(22), 2262-2272. doi:10.1001/jama.2021.7444

This article presents the findings of the research done by Martens et al. (2021). This study was done with the aim of finding the impacts of continuous glucose monitoring in improving individuals’ HbA1c levels when compared to the impact of blood glucose meter monitoring. In a randomized controlled trial, these researchers recruited a total of 175 people with type 2 diabetes. While the individuals in the intervention group used continuous glucose monitoring, the ones in the control group engaged in blood glucose meter monitoring. This study was done for a period of eight months. Upon analyzing the data, it was noted that the individuals in the intervention group showed a substantial reduction in HbA1c levels (p-value of 0.02). There was also a significant difference between the intervention and control groups (p-value of 0.001). Mean HbA1c level decreased from 9.1% at baseline to 8.0% at eight months in the continuous glucose monitoring group and from 9.0% to 8.4% in the control group (adjusted difference, −0.4% [95% CI, −0.8% to −0.1%]; p= 0.02). The results imply that continuous glucose monitoring leads to a more significant reduction in HbA1c levels, indicating that the intervention is effective.

Grace, T., & Salyer, J. (2022). Use of Real-Time Continuous Glucose Monitoring Improves Glycemic Control and Other Clinical Outcomes in Type 2 Diabetes Patients Treated with Less Intensive Therapy.  Diabetes Technology & Therapeutics,  24(1), 26-31. DOI: 10.1089/dia.2021.0212.

Authored by Grace & Salyer (2022), this study focused on using real-time continuous glucose monitoring in the management of patients with diabetes type to improve glycemic control. The researchers recruited patients with type 2 diabetes with basal insulin only or noninsulin therapy. At six months, the researcher found relevant outcomes. For example, the participants showed a considerable reduction in HbA1c levels (−3.0% ± 1.3%, p-value <0.001). In addition, the researchers observed a reduction in the average levels of glucose at six months (−23.6 ± 38.8,  P < 0.001). Therefore, continuous glucose monitoring was connected with significant glycemic improvements among patients with type 2 diabetes.

v. Practice Change Recommendation: Validation of the Chosen Evidence-Based Intervention

The standards of diabetes care have been used at the facility for years as a preference. However, this approach has not been as effective as expected. As such, this research proposes to investigate whether the increased prescription of continuous glucose monitoring as an intervention to help patients with type 2 diabetes have improved HbA1c levels, as shown in the research done by Beck et al. (2017). In a randomized controlled trial, the researchers randomized (n=79) patients in a continuous glucose monitoring group while (n=79) were in the control group. The continuous glucose monitoring group used a Dexcom G4 platinum continuous monitoring system to monitor their glucose concentrations to give a better reduction in HbA1c levels as compared to the control group (p values of 0.022). The analysis of the study findings showed that the mean HbA1c levels went down to 7.7 % and 8.0% in the continuous glucose monitoring group and control group, respectively (adjusted difference in mean change, −0.3% [95% CI, −0.5% to 0.0%]; P = 0.022), showing that the intervention was efficacious (Beck et al.,2017). As such, this randomized controlled trial study shows that continuous glucose monitoring can effectively improve HbA1c levels among patients with type 2 diabetes hence a recommendation for practice change (Beck et al., 2017).

vi. Summary of the findings written in this section.

Diabetes is one of the most common and disabling chronic conditions. However, the application of nursing interventions can be key to improving patient outcomes (Beck et al., 2017). From the annotations, it is evident that the use of continuous glucose monitoring as an intervention in managing diabetes leads to a better control in patient’s blood glucose, even though the cost of purchasing it is significantly higher. For example, the researchers reported significant improvement in the HbA1c levels upon the use of continuous glucose monitoring. When the results for the control groups were compared with intervention groups, significant improvements among the intervention groups were observed. For example, the reduction in the HbA1 levels observed between the intervention and control group by Beck et al. (2017) was significant (p= 0.022); Gilbert et al. (2021) observed ( p < 0.001), Heinemann et al. (2019) observed ( p < 0.001); Martens et al. (2021) also observed ( p < 0.001); Grace & Salyer observed (p <0.001)

Describe the variables/groups to project in one sentence.

It is not known if the implementation of the translation of research by Beck et al. (2017) on continuous glucose monitoring to improve the rate of practitioners’ ordering continuous glucose monitoring would impact HbA1c levels among patients with type II diabetes.

Among adult patients with type 2 diabetes in an outpatient clinic, will the translation of Beck et al.’s research on continuous glucose monitoring increase the rate of practitioners ordering continuous glucose monitoring impact HgbA1C compared to current practice in 12 weeks?

Evidence-Based Question:

Provide the templated statement.

To what degree will the implementation of continuous glucose monitoring impact HbA1c levels among adult patients with type two diabetes in an urban outpatient clinic.

Setting

Location

Inclusion and Exclusion Criteria

i) Sample and Sample Size: The sample will be based on a convenient sample of 16 adult patients diagnosed with type 2 diabetes. the sample will then be divided into two, the control group and the intervention group, each having 8 patients. One of the potential biases is selection bias, as the patients recruited will be ones known to the facility and attending the facility for the management of diabetes. Another potential bias is that the samples will be from one center, hence a lack of generalizability.

The sample size of 16 patients is obtained by taking 10% of the total diabetic adults who visit the hospital, which is 160 patients

ii) Setting: The setting for the study is an urban Outpatient care primary clinic.