Recommendations for research

The 2015 Guideline Development Group made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future. The Guideline Development Group's full set of recommendations for research is detailed in the full guideline.

Key recommendations for research

The effects of stopping and/or switching drug treatments to control blood glucose levels

In adults with type 2 diabetes, what are the effects of stopping and/or switching drug treatments to control blood glucose levels, and what criteria should inform the decision?

Why this is important

There is a lack of evidence on the effects of stopping and/or switching drug treatments to control blood glucose levels. The current practice of 'stopping rules' is typically motivated by either inadequate blood glucose control (rising HbA1c levels) or intolerable side effects. There is limited understanding of the short- and long‑term effects of stopping a therapy and switching to another in terms of diabetes control (HbA1c levels), hypoglycaemic risk, weight gain, and cardiovascular morbidity and mortality. In addition, there is limited understanding of how quickly consideration should be given to stopping and switching to another drug treatment and, if stopping and switching may be needed, what the optimal sequencing is of drug treatments. Randomised controlled trials examining these different issues would help to improve diabetes care.

Non-metformin-based drug treatment combinations to control blood glucose levels

In adults with type 2 diabetes, what treatment combinations (for example, glucagon‑like peptide‑1 [GLP‑1] mimetics and insulin combination therapy with meglitinides) are most effective when initial drug treatment with non‑metformin monotherapy fails to adequately control blood glucose levels?

Why this is important

Although it is recognised that metformin therapy is suitable for most adults with type 2 diabetes, its use is contraindicated or not tolerated in approximately 15% of individuals. To date, research evidence has largely focused on metformin‑based treatment combinations. Given the progressive nature of the condition, in which intensification of blood glucose lowering drug therapies are indicated over time, there is little evidence, for some adults, to guide management strategies on treatment combinations that do not include metformin. Randomised controlled trials are therefore needed to better understand the treatment choices that are available which improve blood glucose control and long‑term risks of complications associated with diabetes.

Drug treatment (third intensification) for when blood glucose levels are inadequately controlled by 3 oral antidiabetic drugs and/or insulin combinations

When third intensification of treatment is indicated, which blood glucose lowering therapies should be used to control blood glucose levels?

Why this is important

As the incidence of type 2 diabetes increases in the younger population and as blood glucose control declines naturally over time, it is likely that further intensification of therapies would be needed. Currently, there is evidence up to second intensification of drug therapies, that is, when 2 or more non‑insulin‑based treatment combinations fail to adequately control blood glucose levels. Randomised controlled trials are needed to improve understanding of alternative treatment options for adults at second intensification whose blood glucose is inadequately controlled with insulin and/or triple non‑insulin‑based drug therapies.

Long-term outcomes associated with blood glucose lowering agents

In adults with type 2 diabetes, what are the long‑term effects of blood glucose lowering therapies such as dipeptidyl peptidase‑4 (DPP‑4) inhibitors, sodium–glucose cotransporter‑2 (SGLT2) inhibitors and meglitinides?

Why this is important

There is limited evidence in relation to the long‑term effects (at least 5 years) of blood glucose lowering therapies, particularly newer agents in terms of efficacy and adverse events (for example, cardiovascular outcomes). Randomised controlled trials and prospective longitudinal studies are needed to better understand the long‑term efficacy and safety issues surrounding these medicines.

Self-monitoring of blood glucose levels

What is the optimal frequency for self‑monitoring of blood glucose in adults with type 2 diabetes?

Why this is important

It is widely recognised that self-monitoring of blood glucose is a multicomponent intervention. As well as being educated about how to use a self‑monitoring device to assess blood glucose levels, adults with type 2 diabetes need to be able to understand their results and act on the observed readings.

In adults for whom self-monitoring is appropriate, there is limited evidence to guide clinical practice in prescribing self‑monitoring regimens, in terms of frequency of testing and optimal blood glucose targets. Given the inconvenience and expense of self‑monitoring, robust evidence from randomised controlled trials is needed to guide the optimal use of this intervention.

Other recommendations for research

The 2021 guideline committee has made the following recommendations for research.

1 Effectiveness of SGLT2 inhibitors for different ethnic groups

What is the clinical and cost effectiveness of SGLT2 inhibitors in adults with type 2 diabetes and chronic kidney disease, stratified across different ethnic groups?

For a short explanation of why the committee made this recommendation for research, see the rationale on SGLT2 inhibitors for adults with type 2 diabetes and chronic kidney disease.

Full details of the evidence and the committee's discussion are in evidence review A: SGLT2 inhibitors for people with chronic kidney disease and type 2 diabetes.

2 Effectiveness of SGLT2 inhibitors for adults with a urine ACR below 3 mg/mmol

What is the clinical and cost effectiveness of SGLT2 inhibitors in adults with type 2 diabetes, chronic kidney disease and a urine ACR of less than 3 mg/mmol?

For a short explanation of why the committee made this recommendation for research, see the rationale on SGLT2 inhibitors for adults with type 2 diabetes and chronic kidney disease.

Full details of the evidence and the committee's discussion are in evidence review A: SGLT2 inhibitors for people with chronic kidney disease and type 2 diabetes.

  • National Institute for Health and Care Excellence (NICE)