Background We don’t know for sure if there is any real increased efficacy of using Insulin Pumps over Regular Insulin Injections in the case of children aged less than 12 years who are affected with diabetes type 1

Background We don’t know for sure if there is any real increased efficacy of using Insulin Pumps over Regular Insulin Injections in the case of children aged less than 12 years who are affected with diabetes type 1

Background We don’t know for sure if there is any real increased efficacy of using Insulin Pumps over Regular Insulin Injections in the case of children aged less than 12 years who are affected with diabetes type 1. Methods We established a searchable question by reviewing available background data, and refining our initial ideas using the PICO frame work. We did a structured search in the PubMed database of NCBI using appropriate keywords and Boolean operators. We utilised appropriate Mesh terms in order to broaden our search. Results It was found out that there was very significant inconsistency in the available literature and the overall rating of the evidence for using Insulin Pumps instead of regularly administered Insulin Injections was Moderate as defined by GRADE standards. However it was noted there was a consistent evidence that using Insulin Pumps led to increased Quality of Life of the patient. Conclusions In conclusion, Insulin Pumps do not seem to have significant evidence that they are more effective than the more traditional syringe and vial methods. However, the physician may put forward a weak recommendation for using them if it is deemed that the increased quality of life would outweigh associated increased costs and other barriers to its use. Introduction Ever since the discovery that diabetes was of two types, type one and type two, where type one was due to the absence of circulating insulin in the body of patients due to the lack of sufficient number of islets of Langerhans in the pancreas, healthcare providers have tried to cure this by introducing insulin into the human body. The disorder has been historically treated through injections of doses of insulin given at regular intervals through subcutaneous injections. In recent years, there has been a new way to treat this condition: Continuous Subcutaneous Insulin Infusion (CSII), also informally known as Insulin Pumps. The purported benefits of this scheme is that there is better control of body insulin levels as a result of which there are decreased number of episodes of hypoglycaemia and hyperglycaemia and at the same time lower risks of side effects like ketoacidosis. However this new method requires some lifestyle modification in order to use it and thus is not always preferred by patients or more commonly their parents. Thus there are two main methods of introducing Insulin into the patients body: Spaced Multiple Injections or MDI (Multiple Daily Injections) and Infusion methods, particularly CSII (Continuous Subcutaneous Insulin Infusion) or Insulin Pumps. Insulin Pens are other devices that are basically a different method of delivery of Insulin into the body essentially being similar to traditional syringe and vial methods of delivery. Other modifications of the system such as introduction of a continuous Glucose Monitor, may be applicable to both MDI as well as SCII and thus are not considered. (Guo and Wang, 2017) The purpose of this study is to investigate whether there is plausible and strong evidence to back using insulin infusion sets also known as insulin pumps in this particular age group (Paediatric age group: 0 – 12 years) as an effective mode of treatment for diabetes type 1. If this study finds sufficient strong evidence that the said treatment is effective, we will proceed to look at whether we can recommend it to US patients of the same age group in exchange of the other mode of treatment. For the purpose of this review, we will be following the recommendations of the GRADE working group in analysing the available evidence (Guyatt et al. 2011). We will be looking at the best available evidence. Here we wish to explicitly state that we will only be considering studies indexed in the NCBI PubMed database and those that have accessible full text at the time of creating this study. Method Having set out with the question: “Can Insulin Pump therapy be recommended over Regular Insulin Injections in the case of Paediatric patients?” we set out to clarify and compartmentalise our question such that we would end up with a well searchable question. First we clearly defined our searchable question using the PICO method (Riva et al. 2012): P : patients in the age group 0-12 years I : Subcutaneous Insulin Infusion C : Insulin Injections given at intervals O: Maintenance of the average blood glucose level in its normal physiological range. It was decided on the basis of our own expertise and opinion that other adverse effects such as ketoacidosis, if caused by the therapy in question, would almost certainly be caused due to changes in blood glucose level over significant periods of time. Hence we chose to set the outcome to maintaining appropriate blood glucose levels which include the sub outcomes of preventing hypoglycaemia and hyperglycaemia. We also noticed on looking at the numerous background articles available, that the majority of the studies and trials looked at glycated haemoglobin A and not directly at blood glucose levels due in part to the fact that for accurate estimations of blood glucose and its relation to diabetes, fasting blood glucose would have to be measured. Having decided to utilise the PubMed Database, we proceeded to utilise its Mesh (Medical Subject Headings) table to help us in broadening our search strategy. The search strategy we used was to utilise the appropriate Mesh terms to expand our search parameters easily. We used the following search string to obtain the main list of studies: (“Insulin Infusion Systems”Mesh AND “Insulin”Mesh AND “Injections”Mesh) AND (“Blood Glucose”Mesh OR “Hypo glycemia”Mesh OR “Hyper glycemia”Mesh) This led to 312 results, however we had not yet added an age filter. Adding it to the search, we obtained 72 results, which diminished to 54 on adding the full text criterion. From these results we obtained 3 Systematic Reviews of which 2 were also meta-analyses. The other systematic review was a clinical guideline report. Besides this, we also obtained 13 Randomised Control Trials, which on further inspection decreased to 8 accepted articles. Articles were rejected on the grounds of being completely out of context. We did not look at observational studies and all our observations are drawn from these articles. Here is the list of searches used: 1. (“Insulin Infusion Systems”Mesh AND “Insulin”Mesh AND “Injections”Mesh) AND (“Blood Glucose”Mesh OR “Hypo glycemia”Mesh OR “Hyper glycemia”Mesh) – 312 results 2. (“Insulin Infusion Systems”Mesh AND “Insulin”Mesh AND “Injections”Mesh) AND (“Blood Glucose”Mesh OR “Hypo glycemia”Mesh OR “Hyper glycemia”Mesh) AND (“child”MeSH Terms:noexp OR “infant”MeSH Terms OR “child, preschool”MeSH Terms) – 72 results 3. (“Insulin Infusion Systems”Mesh AND “Insulin”Mesh AND “Injections”Mesh) AND (“Blood Glucose”Mesh OR “Hypo glycemia”Mesh OR “Hyper glycemia”Mesh) AND (“child”MeSH Terms:noexp OR “infant”MeSH Terms OR “child, preschool”MeSH Terms) AND “loattrfull text”sb – 54 results 4. (“Insulin Infusion Systems”Mesh AND “Insulin”Mesh AND “Injections”Mesh) AND (“Blood Glucose”Mesh OR “Hypo glycemia”Mesh OR “Hyper glycemia”Mesh) AND ((systematicsb OR Reviewptyp OR Meta-Analysisptyp OR Randomized Controlled Trialptyp OR Clinical Trialptyp) AND (“child”MeSH Terms:noexp OR “infant”MeSH Terms OR “child, preschool”MeSH Terms)) – 32 results And here is the table of articles we reviewed: Sl. No. Study (Harvard Reference) Type Accepted/not w/ reason Initial Rating Final Rating 1 Benkhadra, K., Alahdab, F., Tamhane, S.U., McCoy, R.G., Prokop, L.J. and Murad, M.H., 2017. Continuous subcutaneous insulin infusion versus multiple daily injections in individuals with type 1 diabetes: a systematic review and meta-analysis Systematic Review + Meta-analysis Accepted High Moderate (component studies have moderate risk of bias) 2 Jeitler, K., Horvath, K., Berghold, A., Gratzer, T.W., Neeser, K., Pieber, T.R. and Siebenhofer, A., 2008. Continuous subcutaneous insulin infusion versus multiple daily insulin injections in patients with diabetes mellitus: systematic review and meta-analysis Systematic Review + Meta-analysis Accepted High Low (Indirectness of results, Only one children’s study was considered which came up inconclusive) 3 Danne, T., Bangstad, H.J., Deeb, L., Jarosz?Chobot, P., Mungaie, L., Saboo, B., Urakami, T., Battelino, T. and Hanas, R., 2014. Insulin treatment in children and adolescents with diabetes. Pediatric diabetes, 15(S20), pp.115-134 ISPAD Guidelines Clinical Practice Consensus Guidelines 2014 Accepted High High 4 Bergenstal, R.M., Tamborlane, W.V., Ahmann, A., Buse, J.B., Dailey, G., Davis, S.N., Joyce, C., Perkins, B.A., Welsh, J.B., Willi, S.M. and Wood, M.A., 2011. Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month continuation phase. Diabetes Care, 34(11), pp.2403-2405 RCT Not accepted (Not RCT but rather Follow up to RCT) 5 Bergenstal, R.M., Tamborlane, W.V., Ahmann, A., Buse, J.B., Dailey, G., Davis, S.N., Joyce, C., Perkins, B.A., Welsh, J.B., Willi, S.M. and Wood, M.A., 2011. Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month continuation phase. Diabetes Care, 34(11), pp.2403-2405 RCT (>7 years ) Accepted High Low (Industry Sponsored, Randomisation not possible to hide, Review Committee not known if blinded) 6 Nabhan, Z.M., Kreher, N.C., Greene, D.M., Eugster, E.A., Kronenberger, W. and DiMeglio, L.A., 2009. A randomized prospective study of insulin pump vs. insulin injection therapy in very young children with type 1 diabetes: 12?month glycemic, BMI, and neurocognitive outcomes. Pediatric diabetes, 10(3), pp.202-208 RCT (0-5 years) Accepted High Low (No mention of blinding of adjudication committee, Very low sample size) 7 Skogsberg, L., Fors, H., Hanas, R., Chaplin, J.E., Lindman, E. and Skogsberg, J., 2008. Improved treatment satisfaction but no difference in metabolic control when using continuous subcutaneous insulin infusion vs. multiple daily injections in children at onset of type 1 diabetes mellitus. Pediatric diabetes, 9(5), pp.472-479 RCT (>7 years) Accepted High Low (Open, not blinded, moderate sample size) 8 Nuboer, R., Borsboom, G.J., Zoethout, J.A., Koot, H.M. and Bruining, J., 2008. Effects of insulin pump vs. injection treatment on quality of life and impact of disease in children with type 1 diabetes mellitus in a randomized, prospective comparison. Pediatric diabetes, 9(4pt1), pp.291-296 RCT (> 4 years) Accepted High Low (Not blinded, moderate sample size) 9 Fox, L.A., Buckloh, L.M., Smith, S.D., Wysocki, T. and Mauras, N., 2005. A randomized controlled trial of insulin pump therapy in young children with type 1 diabetes. Diabetes care, 28(6), pp.1277-1281 RCT (12 – 72 months) Accepted High Low (Similar reasons) 10 Weintrob, N., Schechter, A., Benzaquen, H., Shalitin, S., Lilos, P., Galatzer, A. and Phillip, M., 2004. Glycemic patterns detected by continuous subcutaneous glucose sensing in children and adolescents with type 1 diabetes mellitus treated by multiple daily injections vs continuous subcutaneous insulin infusion. Archives of pediatrics & adolescent medicine, 158(7), pp.677-684 RCT (>8 years) Accepted HIGH Low (similar reasons) 11 Weintrob, N., Benzaquen, H., Galatzer, A., Shalitin, S., Lazar, L., Fayman, G., Lilos, P., Dickerman, Z. and Phillip, M., 2003. Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens in children with type 1 diabetes: a randomized open crossover trial. Pediatrics, 112(3), pp.559-564 RCT Accepted HIGH Low (similar reasons to above) Results: In evaluating the quality of evidence found in this review, we used the GRADE system (Guyatt et al. 2011). Of all the articles we found, only the ISPAD guidelines were evaluated to have a High level of evidence and all other articles were evaluated to have moderate to low levels, with most of the RCTs providing a low level of evidence. All evaluated RCTs were found to be non blinded which was to be expected given the obvious nature of the experiment, however there was no RCT that explicitly mentioned blinding of the adjudication committee which would have been the next best step. Further more one study was industry sponsored and by the very company which made the SCII devices. Such a study was subsequently deemed to have a higher level of publication bias than others in the results. There is a very high level of inconsistency in the evidence, with the majority of the smaller sample RCTs claiming that there was either little or no advantage of SCII compared to MDI with respect to metabolic parameters, particularly blood glucose level. However, a New England Journal of Medicine published RCT claimed that there was a significant improvement in this regard. One of the factors that contributed to the heterogeneity was the fact that the trials didn’t agree upon the exact method of administering MDI to the patients in question. Some studies followed a regimen of four injections while others went higher. The data found was also very heterogeneous with studies that ranged from focussing on solely children 1 to 3 years of age to studies that looked at children that were above 8 years of age. Keeping all this heterogeneity in mind, and also the overall moderate level of evidence for the original question, we decide that there is not enough evidence for us to recommend SCII over MDI particularly due to effectiveness. However we believe certain other advantages are present in SCII systems which might make their use attractive to some people in this category. Quite a few trials that looked at the issue also looked at patient’s quality of life. In these cases, we see an uniform trend of higher quality of life when using SCII systems. Discussion We note that the use of SCII has several barriers to its use in treating Diabetes type 1 in this group of patients, including the higher cost of treatment and the change in the mode of living of the patients. In this regard we recommend that this therapy may only be offered as a weak recommendation, as its slightly increased quality of life does not justify the increased cost and technical care required for it. Clinicians and Physicians should carefully observe this and explain this to the patients. In the event that this therapy is considered we recommend replacing it into the normal lives of patients while swapping out the usually used MDI treatment protocols. We recommend monitoring the outcome of the therapy preferably by direct blood sugar estimation. However we realise the possibility that a direct blood glucose estimation would nullify the main advantage of the therapy from the eyes of the patient: fewer injections per day. In this regard we also recommend an alternative method of measuring the outcome of the therapy and that is glycated haemoglobin A estimation. Barriers to therapy are circumstances that act against the adoption of that particular therapy. Enablers are the opposite, being circumstances that can help increase adoption of the therapy. Here we look at some barriers and enablers to use of Insulin Pump therapy. We group the barriers and their corresponding enablers together under two headings: Parent perceived barriers, and Physician related barriers. Parent perceived barriers: A study done in June 2017 looked at the parent perceived barriers in the case of use of insulin pumps in their children (Commissariat et al 2017). The parents were asked to list the possible reasons why they did not allow their children to access CSII even when it was physician recommended. The most widely cited perceived group of barriers was physical interference (Uncomfortable to wear, Interference with sports and activities, Using the insertion sets/tubing, Skin reactions from the insertion site/adhesive, Having a device on body, Pump would be too big). Besides these perceived barriers, the other main groups of barriers are: Therapeutic effectiveness and Financial burden. From this it is clear that there are several misconceptions regarding CSII in many parents. The obvious enabler in this regard is parent education by healthcare providers. This will decrease the number of parents who deny this treatment to their children. A notable set of barriers quoted under Therapeutic effectiveness was, (Pump too complicated for family to use, Pump too complicated for other care providers to use, Not enough advice/guidance from HCP on how to use pump). It appears that there is also a lack of technical knowledge in both the parents and the care providers. This lack of technical knowledge can be an important barrier in the adoption of CSII. An appropriate enabler that will counter this is, increased technical knowledge of healthcare providers, perhaps through manufacturer sponsored conferences. Physicians can consequently educate the parents. Financial burden remains a stubborn barrier, as it does in any sufficiently advanced therapy. Perhaps with advancements in the technology, costs will come down in future leading to greater adoption. Physician related barriers: There are relatively few studies focussing on healthcare providers attitudes to CSII, however an old study done in 2003 in Denmark (Nørgaard 2003) indicated a lack of sufficient awareness about the advancements and advantages of the therapy leading healthcare providers to avoid prescribing the therapy. The appropriate enabler in this case is better physician education. Dissemination of the results: The results of this study should ideally be published in an appropriate peer-reviewed journal that will then enable our fellow professionals and researchers to access the findings easily. Also the findings should be disseminated in mainstream media outlets in appropriate language and without losing too much detail. Limitations of the study • There was only one person who looked at the data and estimated the grade of the associated evidence. This could almost certainly lead to bias in the results, however in this regard, the investigator has stated that she has tried her utmost to maintain the impartiality of the process. • Only one database was queried and there could have been more appropriate search terms that could have turned up a higher number of evidence. In this regard the findings of the article are limited in their strength. Conclusion The use of SCII or Insulin Pumps over MDI in the case of paediatric patients which are of ages less than 12 is not significantly more effective based on the analysis of the currently available literature. The treatment however has been found to offer a slightly higher quality of life as compared to the traditional treatment and hence may be weakly recommended. Treatment barriers will need to be overcome before prescribing such a therapy and also there should be adequate explanation of the advantages and disadvantages of such a therapy.


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