Background
Objectives of the systematic review
Methods
Systematic review design
Population/participants
Interventions
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Multiple daily injections (MDI): (basal bolus)
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Self-monitoring of blood glucose via capillary testing (SMBG)
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Continuous subcutaneous insulin infusion (CSII) systems, CSII with a low-glucose suspend feature, CSII with a predictive low-glucose suspend feature, hybrid closed-loop CSII systems, closed-loop (insulin only or insulin and glucagon) CSII systems
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Continuous glucose monitors (CGM)
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Flash glucose monitors (FGM)
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Insulin bolus calculators
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Smart device applications
Comparator
Outcomes
Primary outcomes
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HbA1c results:
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◦ Achieving targets:
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■ < 6.5% (48 mmol/mol)
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■ ≤ 7.0% (53 mmo/mol)
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■ ≤ 8.0% (64 mmol/mol)
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◦ Change from baseline HbA1c % (mmol/mol)
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Hypoglycaemia:
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◦ Frequency and total number of events per unit of time
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◦ Severity category if provided by clinical trial:
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■ Level 1: 3.0 mmol/L (54 mg/dL) ≤ BGL < 3.9 mmol/L (70 mg/dL)
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■ Level 2: BGL < 3.0 mmol/L (54 mg/dL).
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■ Level 3: altered mental and/or physical status requiring third party assistance
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◦ Emergency services and/or hospital presentation or admission if provided
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Costs for economic evaluations:
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◦ Direct and indirect if provided
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◦ Incremental cost-effectiveness ratio (ICER)/quality-adjusted life-years (QALYs)
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Secondary outcomes
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Hyperglycaemia:
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◦ Frequency and total number of events per unit of time
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◦ Severity category if provided:
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■ Elevated: 10.0 mmol/L (180 mg/dL) < BGL ≤ 13.9 mmol/L (250 mg/dL)
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■ Very elevated: BGL > 13.9 mmol/L (250 mg/dL)
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◦ Emergency services and/or hospital presentation or admission if provided
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Measured average blood glucose level (BGL)
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Estimated average blood glucose level
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Time in target/above or below target
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◦ Percentage of BGLs in the range of 3.9 mmol/L (70 mg/dL)–10.0 mmol/L (180 mg/dL) per unit of time
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Average fasting and post-prandial glucose levels in mmol/L (mg/dL)
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Average total daily dose of insulin being administered
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◦ Insulin sensitivity factors (and how calculated)
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◦ Insulin/carbohydrate ratios (and how calculated)
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Number of episodes of diabetic ketoacidosis (DKA) per unit of time of follow-up
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◦ Number of episodes of ketosis without DKA per unit of time
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■ Blood ketones: positive, or ≥ 0.6 mmol/L
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■ Urine ketones: positive, or ‘moderate to large’
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◦ Number of ketone tests per unit of time
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CSII and/or CGM discontinuation apart from trial protocol
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Measure of health-related quality of life using a validated tool, if provided
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Measure of health literacy/self-efficacy, if provided
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Engagement with health services, if provided
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◦ Number of clinic visits per unit of time
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◦ Number of clinics where the patient failed to attend per number of clinic visits offered per unit of time
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Complications of diabetes:
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◦ Diabetic retinopathy, peripheral neuropathy, nephropathy/end-stage kidney disease (ESKD), ischaemic heart disease (IHD), cerebrovascular accident (CVA), peripheral vascular disease (PVD), and autonomic neuropathy
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Mortality
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Measure of morbidity/Charlson Comorbidity Index (CMI) if detail provided
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Patient acceptability of testing method and method of insulin delivery
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Anxiety about hypoglycaemia or hyperglycaemia
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Adverse events from testing or treatment
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◦ False results: significant disagreement when comparing technology-based measurement system with gold standard (if provided)
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◦ Treatment errors: if measurement system or delivery system fails to perform its function (i.e. unintentionally stops measuring blood glucose or unintentionally stops delivering insulin/glucagon)
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Setting
Study design
Search methods
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MEDLINE
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MEDLINE in-process and other non-indexed citations
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EMBASE
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PubMed
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All evidence-based medicine reviews, incorporating:
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◦ Cochrane Database of Systematic Reviews (via Wiley Online Library)
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◦ American College of Physicians Journal Club
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◦ Database of Abstracts of Reviews of Effects (via Wiley Online Library)
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◦ Cochrane Central Register of Controlled Trials (via Wiley Online Library)
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◦ Cochrane Methodology Register (via Wiley Online Library)
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◦ Health Technology Assessment (via Wiley Online Library)
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◦ NHS Economic Evaluation Database
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EconLit (EBSCOHost)
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Cost-effectiveness Analysis Registry (www.cearegistry.org)
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Research Papers in Economics (http://repec.org/)
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Web of Science
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PsycInfo
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CINAHL
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PROSPERO (www.crd.york.ac.uk/prospero/)
Inclusion of studies
Assessment of methodological quality
Quality of evidence
Data extraction
Data analysis and synthesis of evidence
Subgroup analysis
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Failure to reach target HbA1c despite intensive therapy
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Poor HbA1c (> 9.0%) despite intensive therapy
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Those experiencing severe hypoglycaemia, frequent hypoglycaemia, or impaired hypoglycaemia awareness
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Those with pre-existing microvascular or macrovascular complications from diabetes
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Those with high levels of diabetes distress
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Diabetes duration