Table 3

Secondary objectives

Source documentParameter
112-month and 24-month hypoglycaemia recall, anonymisedRates of SH expressed as number per person per year with specific outcomes as documented on anonymised recall forms, namely SH with:(1) loss of consciousness or seizure;2
(2) administration of glucagon or intravenous glucose;
(3) ambulance call outs
(4) accident and emergency attendances;
(5) hospital admissions (one night or more) for SH.
212-month and 24-month hypoglycaemia recall forms, openRates of moderate hypoglycaemia episodes.*
3Centrally measured blood testChange in HbA1c.†
4Open questionnaireThe Gold score, in which people rank their awareness of hypoglycaemia from 1 (I am always aware) to 7 (I am never aware), will be used to measure improvement in hypoglycaemia awareness, in terms of both mean total scores and the proportion of people achieving Gold score of less than 4.
Mean total score.
46

Proportion of people achieving Gold score of less than 4.
5A modified Clarke score, an eight-item questionnaire for hypoglycaemia awareness status, which includes a measure of SH frequency.Mean total score47
Proportion of people achieving Gold score of less than 4.
The Attitudes to Awareness questionnaire to measure change in beliefs and cognitions around hypoglycaemia described by people with IAH that are unhelpful.Total scores.49
The Hypoglycaemia Fear Survey II.Total score.50
Subscale score for worry.
Subscale score for behaviour.
The Hyperglycaemia Avoidance Survey.Total score.51
Subscale score for worry.
Subscale score for behaviour.
The Problem Areas in Diabetes.Total score.52
Hospital Anxiety and Depression ScoresTotal score.53
Subscale score for anxiety.
Subscale score for depression.
  • *Defined as any episode of low plasma glucose, which was self-treated but where the hypoglycaemia caused significant interruption of current activity, such as having caused impaired performance or embarrassment or having woken the person during sleep, ideally but not necessarily confirmed by a plasma glucose measurement, expressed as number of episodes in the 1 month (4 weeks) preceding the measurement.

  • †Proportion of people in whom HbA1c did not deteriorate, using a rise in HbA1c from baseline as evidence of lack of deterioration in overall diabetes control (ie, people with lower HbA1c, or an HbA1c rise of 0.3% or less will be coded as 1, people with an HbA1c rise of >0.3% will be coded as 0).

  • HbA1c, glycated haemoglobin; IAH, impaired awareness of hypoglycaemia; SH, severe hypoglycaemia.