Table 4

Ancillary analyses

Study titlePopulation studiedOutcomesReferences
1Outcomes for people with low concern about hypoglycaemia at baseline.Participants expressing low concern on the baseline Hypoglycaemia Fear Survey II, defined as those with scores ≤25th percentile in a routine clinic survey.Primary outcome and secondary outcomes 1, 2 and 4. 50
2Comparison of different methods for collecting data about SH in studies.All participants.Descriptive study comparing rates of SH recalled on anonymised 12-month and 24-month recall forms (figure 1) with data collected on:

  1. Open recall forms.

  2. Relatives’ recall forms.

  3. GP recall forms.

  4. Items 3 and 4 of the Clarke scores.

  5. Immediate reporting on form A (adjudicated).

  6. Monthly reports on form B.

3Descriptive analysis of the fidelity with which each intervention is delivered.Audio tapes of group sessions made with participants’ consent (relatives’ information sheet, online supplementary file 3).Trial psychologist and independent assessors will use a novel rating tool adapted from the Assessment of Motivational Interviewing Groups – Observer Scale for quality assurance and evidence of cross contamination. 62
4Hypoglycaemia recorded by CGMSubstudy of 24 (12 in each group) participants who will undertake blind CGM for 2 weeks at baseline and at 12 months postrandomisation.Differences in exposure to CGM measures of hypoglycaemia, namely, (1) alerts (number per week); and (2) glucose recordings of: (A) under 3.9 mmol/L; (B) under 3 mmol/L; and (C) under 2.2 mmol/L, as both event rate (number of events of at least 15 min duration per person per week, separated by at least 15 min from an earlier event) and duration (total time spent at these values in hours and minutes per week).

  • CGM, continuous glucose monitoring; GP, general practitioner; SH, severe hypoglycaemia.