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In patients with type 1 diabetes, does continuous blood glucose monitoring (CBGM) and insulin administration via tubeless insulin pump compared to self blood glucose monitoring (SBGM) and multiple daily injections (MDI) significantly impact HbA1c levels?

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OmniPod Continuous Insulin Management System

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OmniPod Continuous Insulin Management System

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The OmniPod Insulin Management System: the Latest Innovation in Insulin Pump Therapy (Zisser, 2010).
-Discusses the device, including benefits and limitations, and product enhancements, while referring to clinical study data. The innovative design and technology of the OmniPod® system has resolved limitations brought about by traditional insulin pump systems. These limitations include long tubing, complicated components used during setup and maintenance of the system, and the limited number of locations that allow for insertion of the infusion set

OmniPod Insulin Management System: patient perceptions, preference and glycemic control (Zisser & Jovanovic, 2006).
-Discusses results when switching twenty patients from continuous subcutaneous insulin injections (CSII) to the OmniPod for thirty days.
-Eighteen out the twenty participants (20%) preferred the use of the OmniPod compared to their current blood glucose monitoring and insulin management regimen.
-Patient preference was also preferred in the areas of convenience, pain, and satisfaction when wearing during daily routines such as sleeping and showering.
-Additional information recorded during the exit questionnaire by the participants concluded that the OmniPod system may have additional benefits that should be studied further, including A1C results.

Efficacy of the OmniPod Insulin Management System on Glycemic Control in Patients with Type 1 Diabetes Previously Treated with Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion (Layne, Parkin & Zisser, 2016)
-Multicenter, Retrospective study
-Conducted due to the reason that a large cohort of patients has yet to be studied when evaluating a tubeless patch pump for continuous insulin infusion.
-Included results from October 2014 and May 2015 at 461 clinical sites throughout the United States. The study included patients of all ages; pediatric (23.4%), adolescent (12.6%), and adult (64.0%).
-The overall results of the study concluded showing an improvement in the frequency of hypoglycemic episodes, a reduction in A1C levels and hypoglycemic episodes, and overall satisfaction with the insulin management system.

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Continuous Blood Glucose Monitoring (CBGM) & Self Blood Glucose Monitoring (SBGM)

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Continuous Blood Glucose Monitoring (CBGM) & Self Blood Glucose Monitoring (SBGM)

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Recovery of Hypoglycemia Awareness in Long-standing Type 1 Diabetes: A Multi-center 2x2 Factorial Randomized Controlled Trial Comparing Insulin Pump with Multiple Daily Injections and Continuous With Conventional Glucose Self-monitoring (Little, Leelarathna, Walkinshaw, et al., 2014).
- 24- week multifactorial randomized study
-Purpose of the study was to improve awareness of hypoglycemia and prevent severe hypoglycemic episodes by comparing MDI & CSII and CBGM & SBGM.
-Hypoglycemia awareness was validated by the Gold & Clark questionnaires.
-Participant requirements: mean diabetes duration of 29 years. 97% were using MDI and 3% were using CSII (96 total participants).
-Results: Improved compliance to their treatment and monitoring regimen and awareness of hypoglycemia.

The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomized controlled trial (Battelino, Conget, Olsen, Schutz-Fuhrmann, et al., 2012).
-Purpose is to determine the effectiveness of including CBGM to CSII.
-Randomized, controlled crossover study
-January 2008-July 2010
-153 Participants: Children and adults between 6 and 70 years old using CSII, and a HbA1c between 7.5-9.5%
-Used a sensor on/off method, participants were randomized into two groups. All wore a continuous blood glucose monitor, which they were blinded to as the screen was turned off.
-Results: CBGM can result in decreased A1c levels and also decrease the amount of time spent in hypoglycemia.

Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults with Type 1 Diabetes Treated with Multiple Daily Injections: The GOLD Randomized Clinical Trial (Lind, Polonsky, Hirsch, Heise, et al., 2017).
-Purpose of the Open-label crossover, randomized trial was to evaluate the effects of CBGM on patients using MDI as treatment regimen.
-Patients were assessed at weeks 1, 2, 4, 13, and 26; A1c measured at each visit.
Results: The mean A1c dropped from 8.6%  to 7.92%.

Glycemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomized controlled trials using individual patient data (Pickup, Freeman & Sutton, 2011).
-Purpose was to measure the effectiveness of real time CBGM compared with SBGM in Type 1 Diabetes.
-2 step meta-analysis of random controlled trials. Total of 6 trials identified with 892 participants. Requirements for participants/trials included diagnosis of type 1 diabetes, the trials had to have a control group, and include real time CBGM.
-Results concluded that CBGM showed a greater reduction in HbA1c levels compared to SBGM.

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Multiple Daily Injections (MDI) vs. Continuous Subcutaneous Insulin Infusion (CSII)

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Multiple Daily Injections (MDI) vs. Continuous Subcutaneous Insulin Infusion (CSII)

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Glycemic Control During Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Insulin Injections in Type 2 Diabetes: Individual Patient Data Meta-analysis and Meta-regression of Randomized Controlled Trials (Pickup, Reznik, & Sutton, 2017).
-Meta-analysis, meta-regression study researched randomized controlled trials and selected ones based on HbA1c during CSII vs MDI.
-A total of five trials were identified as appropriate for randomization.
-Results of the meta-analysis concluded an overall decrease in final and overall insulin dose needed, HbA1c levels, and that glycemic control is better achieved in CSII than MDI in patients with Type 2 Diabetes that is poorly controlled.

Switching to Multiple Daily Injections in Children and Adolescents with Type 1 Diabetes: Revisiting Benefits from Oman (Sharef, Ullah, Al-Shindhani, Al-Farsi & Al-Yaarubi, 2015).
-Retrospective cohort study
-Initially included children that were on multiple regimens for insulin administration including MDI, twice daily (BID), and insulin pump therapy, but only the children receiving insulin BID for a minimum of six months prior to switching to MDI were included in the study.
-Initial HbA1c levels, body mass index (BMI), and daily insulin dose were obtained from the Hospital Information System (HIS).
-The study lasted six months and during that time, participants were evaluated at a clinic every 3 months and after switching to MDI. HbA1c levels were taken at three, six, and nine months. The results of this study show significant changes in HbA1c levels, with even more significant reductions during the three, six, and nine month checks with an average decrease of 1.48%. Reductions in A1C were more prominent in children aged 5-11 years with an average decrease of 1.86%.

A Comparison of Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Injection in Children with Type I Diabetes in Kuwait: Glycemic Control, Insulin Requirement, and BMI (AbdulRasoul, Mousa, Al-Mahdi, Al-Sanaa, et al., 2015).
-Retrospective study
-Included a population of 652 patients, 326 on CSII and 326 on MDI, diagnosed with Type 1 Diabetes
-Data collected between 2007 and 2012.
-Patients were biometrically matched as well as with age at diagnosis, insulin requirement, and glycemic control.
-Results of this study concluded the main reasons for switching to CSII; achieve restored glycemic control, improve quality of life, and reduce instances of hypoglycemia.

Reduction in Severe Hypoglycemia with Long-Term Continuous Subcutaneous Insulin Infusion in Type I Diabetes (Bode, Steed, & Davidson, 1996).
-Crossover study
-Evaluated patients that switched from multiple daily injections (MDI) to continuous subcutaneous insulin infusion (CSII) and their incidence of severe hypoglycemia.
-Criteria included an HbA1c over 8%, subpar glycemic control evidenced by fluctuation blood glucose readings, unawareness of causes of hypoglycemia, and reoccurring hypoglycemic episodes.
-Results of the 55 patients concluded that there was not a significant change in glycemic control, yet the number of severe glycemic episodes decreased from 84 to 8 per 100. The study concluded that the use of CSII showed major improvements in HbA1c and a sustained decrease in severe hypoglycemic events.

Three-year comparison of subcutaneous insulin pump treatment with multi-daily injections on HbA1c, its variability and hospital burden of children with type 1 diabetes (Fendler, Baranowska, Mianowska, Szadkowska & Mlynarski, 2011).
-Prospective observational study based on a database of discharge summaries of all children with Type 1 Diabetes.
-Data collected from 2002-2008, follow-up until December 2010.
-Population included 231 patients on MDI and 223 on CSII. Characteristics of participants included high A1c levels, dawn phenomenon, frequent hypoglycemia episodes, willingness to improve their quality of life
-Results showed a slower deterioration of A1c levels, patients showed better metabolic control with CSII, and that switching from MDI to CSII reduced the annual length of hospitalization.

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-Key search terms: subcutaneous insulin infusion (CSII), multiple daily injections (MDI), OmniPod, insulin pump, type 1 diabetes, insulin therapy, and HbA1c.
-Online databases used when searching on Jacksonville University’s online library database include PubMed, Cochrane, and Medline.
-Personal requirements and guidelines used for research purposes included articles that were peer-reviewed, in the English language, six years old or later, unless specific to the OmniPod® system.

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-Continuous subcutaneous insulin infusion (CSII) via an insulin pump has been around for about 40 years
-Patients with Type 1 Diabetes can be on multiple insulin regimens
-There has been little research between CSII and multiple daily injections (MDI) to determine the best method for glycemic and HbA1c control.
-Many patients with diabetes do not meet their target for A1c.
-Newly diagnosed patients can become confused about their insulin administration regimen and monitoring schedule

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Nursing Theorist: Dorothea Orem (Self-Care Deficit)

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Nursing Theorist: Dorothea Orem (Self-Care Deficit)

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Health deviation self-care is required in conditions of illness, injury, or disease. These include:

1. Seeking and securing appropriate medical assistance

2. Being aware of and attending to the effects and results of pathologic conditions

3. Effectively carrying out medically prescribed measures

4. Modifying self-concepts to accept onseself as being in a particular state of health and in specific forms of health care

5. Learning to live with the effects of pathologic conditions.

http://www.nursing-theory.org/theories-and-models/orem-self-care-deficit-theory.php

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The purpose of this study is to evaluate the effectiveness of continuous subcutaneous insulin infusion (CSII) on patients with Type 1 Diabetes, compared to multiple daily injections (MDI), to determine the method’s effect on overall glycemic control and HbA1c levels.