Real-Time Continuous Glucose Monitoring for People Living With Type 1 Diabetes

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Question(s)

  1. What is the clinical effectiveness of monitoring glycemia with rtCGM for adults living with type 1 diabetes?
  2. What is the clinical effectiveness of monitoring glycemia with rtCGM for pediatric patients living with type 1 diabetes?
  3. What is the cost-effectiveness of monitoring glycemia with rtCGM for people living with type 1 diabetes?

Key Message

  • Continuous glucose monitoring (CGM) is a method of glucose testing in which a sensor is inserted into the skin and continuously monitors interstitial glucose concentrations. Real-time continuous glucose monitoring (rtCGM) systems automatically measure glucose and display a recent glucose value.
  • Evidence suggests that rtCGM may improve hemoglobin A1C and time in range in adults and pediatric patients with type 1 diabetes, but this is uncertain.
  • Limited evidence suggests that in people with type 1 diabetes, there is little to no difference between rtCGM and self-monitoring of blood glucose (SMBG) on quality of life, diabetic ketoacidosis, and severe adverse events.
  • Safety evidence suggests that rtCGM may decrease severe hypoglycemia in adults and pediatric patients with type 1 diabetes, but this is uncertain.
  • rtCGM may be more cost-effective in the long term than SMBG in adults with type 1 diabetes.

Virtual Care Use in Primary Care or Specialty Care Settings

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Question(s)

  1. What are the evidence-based guidelines regarding the appropriate use of virtual care for individuals using primary care or specialty care services?

Key Message

  • Five evidence-based guidelines met the eligibility criteria for this report. Of the 5 guidelines, 2 provided recommendations on rheumatology practice, 1 on stroke, 1 on oncology, and 1 on digital innovations for all areas of health; none of them focused on primary care specifically. Three were developed in the context of COVID-19.
  • While all 5 guidelines were informed by a systematic literature search, some specific recommendations were based on expert consensus, given the absence of literature on the respective topics. The quality of evidence and strength of recommendations, where available, were generally assessed to be low across the guidelines.
  • The evidence-based guidelines provided recommendations across various aspects of virtual care delivery including population considerations, patient conditions, and the types of care that can be offered virtually. They also provided recommendations on when to offer or discontinue virtual care, on patient privacy, and on staff training. One guideline provided a recommendation on fees and reimbursement.
  • Multiple evidence-based guidelines stated that virtual care should complement rather than replace in-person care, and that virtual care should only be implemented when adequate resources and personnel are available and patient privacy can be secured.

Intermittently Scanned and Real-Time Continuous Glucose Monitoring for People With Diabetes

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Question(s)

  1. What is the comparative clinical effectiveness of monitoring glycemia with intermittently scanned continuous glucose monitoring versus real-time continuous glucose monitoring in people with diabetes?

Key Message

Continuous glucose monitoring is a method of glucose testing in which a sensor is inserted into the skin and continuously monitors interstitial glucose concentrations. Real-time continuous glucose monitoring (rtCGM) systems automatically measure glucose and display a recent glucose value. Intermittently scanned continuous glucose monitoring (isCGM) systems require the person using the system to scan the sensor to display glucose information. The evidence of the comparative effectiveness of isCGM versus rtCGM for improving time in range, time above range, A1C, and quality of life in people with type 1 diabetes is uncertain. Evidence from some studies suggested there was a significant benefit favouring rtCGM versus isCGM for these outcomes, whereas other studies found no significant differences between treatment groups. Evidence suggested that people with type 1 diabetes using rtCGM spent significantly less time below range/time in hypoglycemia than those using isCGM. The evidence of the comparative safety of isCGM versus rtCGM in people with type 1 diabetes is limited and uncertain. Evidence from 1 study suggested that severe hypoglycemic events were more frequent in those using isCGM. In other studies, there were no severe hypoglycemic events in either treatment group. No studies were identified that evaluated the comparative effectiveness of isCGM versus rtCGM in people living with type 2 diabetes or gestational diabetes.

Intranasal Glucagon for the Treatment of Hypoglycemia

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Question(s)

  1. What is the clinical effectiveness of IN glucagon versus placebo or no treatment for the treatment of hypoglycemia in people who receive treatment with insulin?
  2. What is the clinical effectiveness of IN glucagon versus alternative interventions for the treatment of hypoglycemia in people who receive treatment with insulin?
  3. What is the cost-effectiveness of IN glucagon versus placebo or no treatment for the treatment of hypoglycemia in people who receive treatment with insulin?
  4. What is the cost-effectiveness of IN glucagon versus alternative interventions for the treatment of hypoglycemia in people who receive treatment with insulin?
  5. What are the evidence-based guidelines regarding the use of IN glucagon for the treatment of hypoglycemia in people who receive treatment with insulin?

Key Message

Intranasal glucagon was equally effective compared with glucagon given by intramuscular or subcutaneous injection to treat experimentally insulin-induced hypoglycemia in both adults and children with type 1 diabetes.

The overall rates of adverse events were similar between groups treated with intranasal glucagon or intramuscular or subcutaneous glucagon. Nausea and vomiting were more frequent in the groups treated with intramuscular or subcutaneous glucagon, whereas eye and nose symptoms occurred more frequently in the intranasal glucagon group.

There was no evidence identified that compared the clinical effectiveness of intranasal glucagon with placebo or no treatment in people treated with insulin who received treatment for hypoglycemia.

No evidence was found about the cost-effectiveness of intranasal glucagon and no evidence-based guidelines were found about the use of intranasal glucagon for the treatment of hypoglycemia in people who receive treatment with insulin.

Melatonin for the Treatment of Insomnia in Children and Adolescents

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Question(s)

  1. What is the clinical effectiveness of melatonin versus no treatment or placebo for the treatment of insomnia in children and adolescents?
  2. What is the clinical effectiveness of melatonin versus prescription sedatives for the treatment of insomnia in children and adolescents?
  3. What is the cost-effectiveness of melatonin versus no treatment or placebo for the treatment of insomnia in children and adolescents?
  4. What is the cost-effectiveness of melatonin versus prescription sedatives for the treatment of insomnia in children and adolescents?
  5. What are the evidence-based guidelines regarding the use of melatonin for the treatment of insomnia in children and adolescents?

Key Message

There is some evidence of benefit of melatonin compared with placebo for the short-term treatment of insomnia in children and adolescents with neurodisabilities.

The short-term safety profile of melatonin suggested that it was well-tolerated, although some severe adverse events may occur. There was a lack of long-term safety data.

The American Academy of Neurology guideline recommends high-grade melatonin should be prescribed for treatment of sleep disturbance in children and adolescents with autism spectrum disorder if first-line treatment with behavioural strategies is not helpful.

Evidence comparing the clinical effectiveness of melatonin with prescription sedatives for the treatment of insomnia in children and adolescents was not identified.

No evidence was found regarding the cost-effectiveness of melatonin compared with placebo or prescription sedatives for the treatment of insomnia in children and adolescents.

Improving Access to Primary Care in Canada

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Primary care is the first point of contact for health and wellness services, coordinating each person’s services in a way that ensures continuity and ease of movement across the system. A strong primary health care system takes a whole-of-society approach to health and well-being and focuses on the holistic needs and preferences of individuals, families, and communities. Access to primary care can have barriers such as culture, language, location, social and economic standing, and in Canada is a known challenge.

Melatonin for the Treatment of Insomnia: A 2022 Update

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Question(s)

  1. What is the clinical effectiveness of melatonin versus no treatment or placebo for the treatment of insomnia in adults?
  2. What is the clinical effectiveness of melatonin versus prescription sedatives for the treatment of insomnia in adults?
  3. What is the cost-effectiveness of melatonin versus no treatment or placebo for the treatment of insomnia in adults?
  4. What is the cost-effectiveness of melatonin versus prescription sedatives for the treatment of insomnia in adults?
  5. What are the evidence-based guidelines regarding the use of melatonin for the treatment of insomnia in adults?

Key Message

Two umbrella reviews, 7 systematic reviews, and 2 randomized controlled trials provided mixed results on the clinical effectiveness of melatonin for insomnia, when compared to placebo. Some studies reported improvement in sleep and quality of life outcomes with melatonin, and some studies reported no difference between patients who received melatonin and those who received placebo. Efficacy of melatonin was measured both objectively (e.g., polysomnography, actigraphy) and subjectively (e.g., validated questionnaires, sleep diaries), and was measured across multiple outcomes. Two guidelines recommend melatonin for insomnia, but the strength of the recommendations was not reported. One guideline recommends melatonin for insomnia, based on very low evidence (but the evidence was unclear). One guideline recommends against melatonin for chronic insomnia disorder (weak recommendation). The evidence for these recommendations was not well reported across the guidelines. No studies were found that evaluated the clinical effectiveness of melatonin compared to prescription sedatives in people with insomnia that met the criteria for this review. No studies were found for the cost-effectiveness of melatonin in people with insomnia that met the criteria for this review.

Vitamin B12 Testing in People with Suspected Vitamin B12 Deficiency

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Question(s)

  1. What is the diagnostic accuracy of vitamin B12 testing for the diagnosis of vitamin B12 deficiency in people with suspected vitamin B12 deficiency?
  2. What is the clinical utility of vitamin B12 testing in people with suspected vitamin B12 deficiency?
  3. What is the cost-effectiveness of vitamin B12 testing in people with suspected vitamin B12 deficiency?
  4. What are the evidence-based guidelines regarding the use of vitamin B12 testing in people with suspected vitamin B12 deficiency?

Key Message

Findings from 3 diagnostic accuracy studies indicate that individual tests are insufficient to diagnose vitamin B12 deficiency, and a testing strategy that uses homocysteine and methylmalonic acid should be used in individuals suspected or at risk of vitamin B12 deficiency. This is supported by a health technology assessment that concluded that the current evidence does not provide enough information to determine the most appropriate test, or combination of tests to use in these patients.

The patient populations varied in the primary studies included in the systematic reviews and in the primary studies identified in this review, which may impact the generalizability of the results.

Reference standards and cut-off values (i.e., thresholds) used to diagnose vitamin B12 deficiency varied in the primary studies. Presentation of units (e.g., pg/mL, pmol/L) also varied, making it difficult to compare results across studies.

No studies were identified that evaluated the clinical utility of vitamin B12 testing in people with suspected vitamin B12 deficiency.

No studies were identified that evaluated the cost-effectiveness of vitamin B12 testing in people with suspected vitamin B12 deficiency.

No evidence-based guidelines were identified regarding the use of vitamin B12 testing in people with suspected vitamin B12 deficiency.