The following key questions were agreed to underpin the development of this SIGN toolkit. 

Environmental and social factors

What factors are associated with optimising glycaemic control in people with type 1 diabetes?

 

Population

Adults, children and young people with type 1 diabetes

Phenomena of interest

Social and environmental barriers and facilitators of glycaemic control

  1. Demographics eg
    • ethnicity
    • deprivation
    • age
    • gender
  2. Ability to make use of technology
  3. Access/availability of interventions
  4. Knowledge and information
  5. Adherence
  6. Health-related quality of life
  7. Relationship/satisfaction with health services

Outcomes

Glycaemic control – clinical measures and as described by person with type 1 diabetes

  • People’s perception, view or self-reported glycaemic control
  • HbA1c
  • Hypoglycaemia
  • Diabetic ketoacidosis (DKA; number of episodes)

Study type

Quantitative and qualitative studies

Notes

Exclude diet and exercise, and comorbidities

Structured education

What is the effectiveness of structured education programmes in improving clinical and patient outcomes in people with type 1 diabetes?

 

Population

Adults, children and young people with type 1 diabetes

Intervention

  • Other education programmes
  • Usual care (no education intervention but including SMBG, CGM or flash glucose monitoring)

Comparator

  • HbA1c
  • Hypoglycaemia - preferably severe hypoglycaemia if reported
  • Diabetic ketoacidosis (DKA; number of episodes)
  • Hospital admissions
  • Hypoglycaemia unawareness
  • Health-related quality of life
  • Adverse events
  • Knowledge
  • Adherence to diabetes management (including self management)
  • Adherence to education intervention
  • Risk-taking behaviour (such as smoking)
  • Satisfaction of people with type 1 diabetes and [their] families with the intervention

Outcomes

Quantitative and qualitative studies

Notes

Question adapted from NICE guidelines NG17, NG18

Psychological interventions

What is the effectiveness of psychological/behavioural interventions to improve outcomes in people with type 1 diabetes?

 

Population

People with type 1 diabetes and their families

Intervention

  • Motivational interviewing
  • Cognitive behavioural therapy (CBT)
  • Counselling
  • Family therapy
    • family-based teamwork
    • behavioural family systems therapy
    • multisystemic therapy
  • Mentoring
  • Peer support

Comparator

  • Each other
  • Usual care/no treatment

Outcomes

  • Diabetes-related emotional distress (including, eg anxiety or depression, PAID scale)
  • HbA1c
  • Adherence to diabetes management (including self management)
  • Health-related quality of life
  • Satisfaction of people [with type 1] diabetes and [their] families with the intervention
  • School [or work] performance or attendance
  • Risk-taking behaviours (such as smoking)
  • Adverse events (for example severe hypoglycaemic episodes, diabetic ketoacidosis [DKA] or self harm)

Notes

Question adapted from NICE NG17, NG18

Glucose-lowering and blood glucose monitoring technologies

Which combination of insulin delivery systems and glucose-monitoring techniques is most clinically and cost effective at optimising glycaemic control:

  • Multiple daily injections (MDI) and self monitoring of blood glucose (SMBG),
  • MDI and continuous glucose monitoring (CGM),
  • MDI and flash glucose monitoring (FGM),
  • Continuous subcutaneous insulin infusion (CSII) and SMBG,
  • CSII and FGM,
  • CSII and CGM?

 

Population

Adults, children and young people with type 1 diabetes.

Intervention

Combined use of:

MDI or CSII, and

SMBG, CGM or FGM

Comparator

All other combinations

Outcomes

  • Hypoglycaemia (including severe or nocturnal hypoglycaemia)
  • HbA1c (minimum follow up 6 months)
  • Adherence to diabetes management (including self management)
  • Health-related quality of life
  • Cost effectiveness

Secondary outcomes (dependent on achievement of primary outcomes)

  • Diabetic ketoacidosis (DKA; number of episodes)
  • Satisfaction of individuals with type 1 diabetes with the intervention

Notes

CSII to consider:

  • tethered pumps
  • patch pumps
  • hybrid closed-loop pumps

 

Cross refer to SHTG advice (Jan 2022)

Glucose metrics

How effectively do:

  • HbA1c
  • time in target range
  • glucose variability (standard deviation around the mean glucose, coefficient of variation, or interquartile range)

predict glycaemic control when used as parameters in glucose monitoring technologies?

 

Population

Adults, children and young people with type 1 diabetes.

Intervention

  • HbA1c
  • time in target range
  • glucose variability (standard deviation around the mean glucose, coefficient of variation, or interquartile range)

Comparator

Each other, or

no comparator (correlation studies)

Outcomes

  • Hypoglycaemia
  • Hyperglycaemia
  • Microvascular complications
  • User understanding/confidence in interpreting results

Notes