Good management of type 1 diabetes mellitus

Do children using insulin pump therapy have improved management of type 1 diabetes compared with children who inject insulin daily?

Good management of type 1 diabetes mellitus (T1DM) is highly important as there are many long-term complications of T1DM including cardiovascular disease, nerve damage and kidney disease. These complications are increased in diabetic adolescents to include impairment of cognition and brain development as well as interference with synapse formation, myelination and neuronal proliferation (Nevo-Shenker et al., 2020).  As type 1 diabetes is typically diagnosed in children, establishing good habits through early education and identifying the most effective management of diabetes is vital to achieve optimal glycaemic control and avoid acute illnesses without compromising health-related quality of life (Mueller-Godeffroy, 2018).

For decades, the universal metric of diabetes management has typically been glycaemic control measured by glycated haemoglobin test (HbA1c) which measures one’s average blood glucose levels over two to three months (Nusca et al, 2018). Effective diabetes management can also be quantified by measuring the amount of insulin required, changes to body mass index (BMI) and the incidence of acute complications such as ketoacidosis, hypoglycaemia and hypoglycaemia (Brorsson et al., 2015). Patients with type 1 diabetes mellitus face a life-long struggle of maintaining their average HbA1c within safe levels to avoid hyperglycaemia while simultaneously avoiding hypoglycaemia. Psychological health in relation to T1DM is also relevant, as the treatment regime can often be a significant burden to both the patient and their families which then affects their ability to effectively manage their T1DM and negatively impacts their overall health related quality of life (Kalra et al., 2018). The articles in this essay will outline changes in health outcomes, specifically management of type 1 diabetes through comparing multiple daily injections versus insulin pump therapy in adolescents.

PICO

  • P = Population
    Children or adolescents with T1DM.
  • I = Intervention
    Insulin pump therapy.
  • C = Comparison
    Multiple daily insulin injections.
  • O = Outcome
    Evidence of improved management of T1DM measured through HbA1C levels, incidence of acute complications/illness, and health related quality of life.

 

Brorsson, A.L., Viklund, G., Örtqvist, E. & Lindholm Olinder, A. (2015). Does treatment with an insulin pump improve glycaemic control in children and adolescents with type 1 diabetes? A retrospective case–control study. Paediatric Diabetes, 16: 546-553. https://doi.org/10.1111/pedi.12209

In this article, the authors used retrospectively collected data from a study carried out between 2005 – 2009 in Stockholm, Sweden. The article analyses the quantitative data collected from the study with the aim to compare the effectiveness of continuous subcutaneous insulin infusion also known as insulin pump therapy (IPT) versus multiple daily insulin injections (MDI) and explore the difference in long-term effects including HbA1c levels, insulin requirements, changes to BMI as well as the incidence of acute complications such as ketoacidosis, hypoglycaemia and hypoglycaemia. This case-control study was conducted in Sweden over 24 months through observing a group of 431 children who were aged between 1-17 years old at the start of the study. There were 216 participants starting on IPT and 215 using MDI. The patients on IPT were all educated prior to the study in relation to ketoacidosis, hypoglycaemic episodes, using the pump, and how to manage pump-related issues. There was a checklist developed to ensure quality and a specialist in paediatrics and endocrinology was responsible for calculating and correcting dosage of insulin as well as educating both parents and patients about ketoacidosis and hypoglycaemic events. The study was conducted over 24 months where all participants were routinely checked every three months by a diabetic nurse or physician who monitored their HbA1c levels, weight and height. Insulin usage was recorded at these 3-monthly visits and with those using IPT, the usage was recorded on their pumps and for those using multiple daily injections the usage was patient reported. The results of the study show that while overall there was a reduction in HbA1c levels for participants using IPT, this was by no means conclusive and was not sustained over the 24 months. At the 6-month stage all of the participants using IPT saw a decrease in HbA1c levels which was sustained after 12 months for the males but not for the females. The study concluded that while the IPT group had improved HbA1c levels, reduced events of severe hypoglycaemia and less insulin required; there was no notable difference in BMI and the IPT group had more incidents of ketoacidosis than the MDI group. The quality of this quantitative study was strengthened by the population of 432 which is considered an acceptable number (Martínez-Mesa et al., 2014) and is impressive considering the specificity of the requirements to participate. The fact that both groups had the exact same HbA1c baseline of 68 is also beneficial in supporting analysis of any differences in this metric. There are some limitations with this study including the fact that only the IPT group were given the pre-study standardisation education which could be a significant factor in outcomes. Another factor that could impair the study’s results are the insulin requirements. Considering the IPT group was recorded through their insulin pump, this number could be much more reliable than patient reported numbers from the MDI group.

The results of this study largely mirror results of previous studies indicating improved HbA1c levels however this study differed in that it showed an increase in incidence of ketoacidosis in the IPT group. While this study showed some data supporting the premise that IPT improves glycaemic control through reducing HbA1c levels in children, the evidence also shows a lack maintenance of this reduction over time and there must be more comprehensive research to confirm the clinical benefits of IPT in children.

Mueller-Godeffroy, E., Vonthein, R., Ludwig-Seibold, C., Heidtmann, B., Boettcher, C., Kramer, M., Hessler, N., Hilgard, D., Lilienthal, E., Ziegler, A., Wagner, V. M., & German Working Group for Pediatric Pump Therapy. (2018). Psychosocial benefits of insulin pump therapy in children with diabetes type 1 and their families: The pumpkin multicenter randomized controlled trial. Paediatric Diabetes, 19(8), 1471–1480. https://doi.org/10.1111/pedi.12777

There is a burgeoning popularity of insulin pump therapy (IPT) use among paediatric patients and the authors of this study theorise that metabolic evidence alone does not necessarily explain this uptake in IPT. This study was a randomised controlled trial conducted between 2011 – 2014 in Germany involving multiple locations and health institutions. The population of this trial initially included 211 adolescents aged between 6-16 years old who had been diagnosed with T1DM for at least 6 months and were already being treated with MDI of insulin. This trial is predominantly a qualitative study collecting data from the patient reported outcomes and caregiver reported outcomes. The aim of this trial was to seek to identify if there are psychosocial benefits of IPT and if they contribute to improved diabetes management and better health outcomes.

The trial was conducted by using a questionnaire with the primary outcomes of rating the patients’ own diabetes specific health-related quality of life (DHRQOL) in which higher scores indicating improved DHRQOL. The participants were interviewed prior to the commencement of IPT to establish a baseline of DHRQOL and again in a 6 month follow up. Their caregivers, who were often their parents were also surveyed using an intensity scale in which measured the burden of diabetes on the caregiver. There were also secondary outcomes in the study including measuring caregiver stress, fear of hypoglycaemia, family conflict, treatment satisfaction and quantitative data such as HbA1c levels.

The results on the group overall indicated an improvement of DHRQOL on average with participants aged between 8-11 years old having the most statistical significance and participants aged between 12-16 having no difference in outcomes.  The other primary outcome being burden of diabetes on caregivers was reported to be significantly lower than the MDI group. The secondary outcomes varied with no reported difference to family conflict but had improved treatment satisfaction, reduced caregiver stress and less fear of hypoglycaemia. There was minimal improvement to glycaemic control as the HbA1c levels recorded only changed slightly however the results of this trial do indicate that there are several psychosocial benefits to IPT and these improvements exist in both the patient’s and caregiver’s experiences. This study is regarded as the largest of its kind and is unique in assessing the data of DHRQOL in paediatric patients. The study was strengthened by its size and participation of 18 diabetic specialist centres. The weaknesses include the lack of participants under 8 years old resulting in no comparison in that age bracket and the follow-up after 6 months only is also quite prohibitive and future studies may benefit from a longer timeframe. There is a major shift in healthcare to focus on person-centred, holistic healthcare that includes all aspects of a person’s life when measuring improved health outcomes. This research provides evidence beyond physiological clinical data to include the patient and their families’ own experiences and improvement to psychosocial metrics which contribute to overall health and wellbeing.

de Bock, Gunn, A. J., Holt, J.-A., Derraik, J. G. B., Reed, P., Cutfield, W., Mouat, F., Hofman, P., & Jefferies, C. (2012). Impact of insulin pumps on glycaemic control in a pump-naïve paediatric regional population. Journal of Paediatrics and Child Health, 48(3), 247–252. https://doi.org/10.1111/j.1440-1754.2011.02245.x

This is a retrospective study analysing data obtained from a diabetes database in Auckland, New Zealand. The study used a quantitative approach to examine the impacts of IPT in children clinically. The aim of the research was to identify additional knowledge to the established research which suggests that IPT only moderately improves glycaemic control and reduces hypoglycaemia.

The research was conducted using a population of 621 children and adolescents in New Zealand who all attended the diabetes paediatric service in Auckland between 2002 and 2008. These patients were all assessed every 3 months at the service and the data recorded included HbA1c levels, self-reported frequency of blood glucose self-monitoring, daily insulin dosage, incidence of hypoglycaemia and diabetic ketoacidosis, and BMI. This study matched 75 patients using IPT with 546 patients on MDI using several metrics including age, diagnosis, ethnicity and gender.

The results of this research indicate a modest improvement of Hb1Ac levels in the IPT group as well as a reduction in risk of hypoglycaemia. While these results are not new and correlate with previous research, this study has shown a maintenance of these improvements for up to 3 years.

The IPT group in this study were mostly of European background with less societal deprivation, were younger at diagnosis and started IPT with better glycaemic control than the MDI group, all of which could affect results of the analysis.  Retrospective studies such as this often have limitations as they are designed to analyse data which already exists, which then results in biases (Talari & Goyal, 2020). There are also some benefits as these studies can be quicker and cheaper to organise than other clinical trials and there is no participation bias.

This study is most beneficial to clinical practice as the data supports IPT as a safe form of treatment, reducing incidence of hypoglycaemia while noting improved rates of glycaemic control over an extended period of time.

 

 

 

 

 

 

Rosner, & Roman-Urrestarazu, A. (2018). Health-related quality of life in paediatric patients with Type 1 diabetes mellitus using insulin infusion systems. A systematic review and meta-analysis. PloS One, 14(6), e0217655–e0217655. https://doi.org/10.1371/journal.pone.0217655

 

This article is a systemic literature review in conjunction with meta-analysis of both quantitative and qualitative data collected from 15 articles using extensive inclusion and exclusion criteria. The authors chose to compare continuous subcutaneous insulin infusion also known as IPT with MDI therapy with the aim to identify which treatment regime is a more effective in relation to improving quality of life (QOL). Secondary outcomes of this review also assessed glycaemic control and incidence of adverse events and discussed front-line use of IPT and its implications to diabetic adolescents. The population of this research was both male and female children or adolescents diagnosed with T1DM aged between 6 months and 19 years and all the articles reviewed had Hb1Ac levels and quality of life as measurable outcomes.

 

The research collected data from the 15 articles which represented clinical trials, randomised controlled trials, cross sectional studies and a prospective observational study. There were many types of assessment tools such as questionnaires used throughout the different articles to measure QOL and where an assessment tool was absent, this study used a Mann-Whitney U test to locate the relationship between adverse events and the treatment groups with the hypothesis that less adverse events determined an improved QOL. The Mann-Whitney U test is a research tool designed to determine statistical differences that are significant between two groups (MacFarland & Yates, 2016) and in this study was used to calculate a standardised mean difference between groups. This qualitative data was then compiled along with quantitative data collected through measuring Hb1Ac levels and incidence of adverse events to provide baseline data and consequently follow up data to measure differences between groups.

 

The results provided slightly improved outcomes for patients undergoing IPT in all metrics including QOL, Hb1Ac levels and reduction in adverse events. These results are consistent with research from previous literature and although they address the aim of the study there is still a lot of research required to investigate the full impact of IPT on children with T1DM.

 

Limitations from this research are numerous and include the ambiguity of the metrics used to evaluate QOL. There were differences in the articles used including study size, location, primary source data, ages and study design. Additionally, the review was limited by differences in reporting, publication bias, and accessibility of studies as only three literature databases were used. The sheer size of the project increases the parameter of the review hugely, but this cannot be seen as entirely positive considering the lack of continuity within the characteristics of this review.

 

The impact of this research to clinical practice would be minimal. The data summarises many studies with mostly similar outcomes however a larger scale more focused singular approach would allow the data to be used with confidence in a clinical setting.

 

Literature evaluation

The articles in this bibliography are varied and collect both qualitative and quantitative data through retrospective studies, a randomly controlled trial and a systemic literature review. These are all valuable types of resources in research but have different purposes and outcomes which should be considered when researching a topic. In retrospective studies, the outcome is already available with data usually collected from existing medical records or from what the patient can recall. While these studies are cheap and quick to establish, they have the potential to include more bias and depend solely on the information that is already entered in the databases (Talari & Goyal, 2020). Randomly controlled trials in health care are studies that measure the effectiveness of a new intervention. The random nature of a trial reduces bias with a carefully selected population who through concealment do not know what group they are allocated to in the study. While this type of research can be expensive it is considered the gold standard for effective, accurate research (Hariton & Locascio, 2018). Xiao & Watson (2019) describe a systemic literature review as an essential feature of academic research which summarises, analyses and synthesises existing related literature to explore gaps and develop new theories.

In conclusion, the literature in this bibliography largely supports the research question and provides evidence that insulin pump therapy does improve effective management of diabetes in children. While there is not a significant difference in outcomes for each metric individually, the combination of improved Hb1Ac levels, reduced incidence of acute complications and improved quality of life show the potential for this intervention so improve health outcomes in type 1 diabetic children.

 

 

 

 

 

 

 

 

 

 

 

 

 

References

*Removed from exemplar.  The student listed 11 references.