Efficacy of injection technique education in diabetes with lipohypertrophy: a systematic review and meta-analysis protocol v2

<p>1.Introduction Many patients with diabetic mellitus who use insulin develop changes in the subcutaneous adipose tissue at the injection site. These lesions are called lipohypertrophy (LH). The prevalence of LH was reported to be 30-50% or more (1). In a randomized crossover study, injections into sites of LH showed blunted insulin absorption and increased variability compared to injections into normal adipose tissues (2). Since sites of LH reduce the absorption of insulin, patients with LH often use higher total daily doses (TDD) of insulin and have worsened glucose control and higher hyperglycemic hemoglobin (HbA1c) levels (3-5). LH may increase the risk of adverse clinical outcomes and the cost of healthcare. Recently, the effect of injection technique (IT) education to avoid the injection into LH and improve glycemic control on patients with LH has been reported (1, 6).IT education includes stopping injections into LH, stopping needle reuse, and rotating injection sites. However, no meta-analysis has been performed. Thus, to assess the impact of IT education on clinical and metabolic parameters in adults with LH, we will summarize current evidence. 2.Research question P: Patients with type 1 diabetes or type 2 diabetes who are injecting insulin and have LH. I: Injection technique education C: standard care O: change in TDD 3.Method 3.1 Protocol We used a systematic review protocol template(dx.doi.org/10.17504/protocols.io.biqrkdv6). We followed the Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 for preparing this protocol(7). We will publish this protocol in protocols.io (https://www.protocols.io/). 3.2 Inclusion criteria of the articles for the review 3.2.1 Type of studies We will include individual, cluster, and cross-over randomized trials that assess the injection technique education in patients with type 1 or type 2 diabetes who are injecting insulin and have LH. We will not apply language or country restrictions. We will include all papers including published, unpublished articles, abstract of conference and letter. We will exclude observational studies and non randomized controlled trials. We will not exclude studies based on the observation period or publication year. 3.2.2 Study participants We will includepatients with type 1 or type 2 diabetes who have been on insulin injections for at least 1 year, with LH, 18 years of age or older, any gender, no HbA1c restriction, and no education about LH within the past 6 months. The diagnosis of LH were made by a physician or nurse when it is clinically visible, palpable, or visible on ultrasound (8). We will accept any number of insulin injections per day, or size of needle or length for insulin injections.. We will exclude pregnant women, patients who wish to become pregnant, lactating women and patients taking medications that may cause LH (anti-retroviral or corticosteroid therapy). 3.2.3 Intervention IT education: Stop injecting into the LH site, stop reusing needles, and rotate injection sites. We will also accept other definitions of IT education. Any education period is acceptable. 3.2.4 Control Standard care (no intervention, usual care). 3.3 Type of outcomes 3.3.1 Primary outcomes 1.Change in total daily doses of insulin Definition: Change in total daily doses of insulin from baseline Period: Time frame is the longest follow-up period after 3 months 2. Change in HbA1c Definition: Change in HbA1c from baseline Period: Time frame is the longest follow-up period after 3 months 3. Hypoglycemia Definition: Hypoglycaemia was defined as the occurrence of one or more symptoms of hypoglycaemia (such as palpitations, tiredness, sweating, strong hunger, dizziness and tremor) and a confirmed blood glucose meter reading of ≤ 60 mg/dL (4). We will also accept hypoglycemia as the original investigators defined. Period: during follow up period 3.3.2 Secondary outcomes 1. Change in proportion of patients with cured LH Definition: as original investigators defined Period: Time frame is the longest follow-up period after 3 months 2. All adverse events Definition: definition of adverse events are set by original authors. Period: during follow up period 3.4 Search method 3.4.1 Electronic search We will search the following databases: 1. the Cochrane Central Register of Controlled Trials (CENTRAL); 2. MEDLINE via PubMed; 3. EMBASE via ProQuest Dialog; See Appendix 1, 2, and 3 for the search strategies. 3.4.2 Other resources We will also search the following databases for ongoing or unpublished trials: 1. the World Health Organization International Clinical Trials Platform Search Portal (ICTRP); 2. ClinicalTrials.gov; See Appendix 4, 5 for the search strategies. We will check the reference lists of studies, including international guidelines as well as the reference lists of eligible studies and articles citing eligible studies. We will ask the authors of original studies for unpublished or additional data ...