Table 3 Hypoglycaemia quality indicator subgroups

Hypoglycaemic events

Reported thresholds^a for defining a BGL as hypoglycaemic event:

• <40 [8, 10, 17–19, 30, 35, 43];

• ≤ 40 [26];

• <45 [44, 54];

• <50 [31, 49, 50];

• <54 [34];

• <57 [32];

• <60 [8, 11, 45, 52, 55];

• ≤ 60 [16, 21];

• <63 [23];

• <65 [25];

• <70 [9, 17, 22, 27, 28, 57];

• <72 [20]; or

• threshold was not reported [48]

Represented as:

• percentage and number of measurements and/or patients with hypoglycaemic event during the trial, or normalized for duration of therapy [16];

• mean or median of events per patient-day [57];

• mean of events per patient [27];

• patients with at least one event per day [22]; or

• in three studies, hypoglycaemic events did not occur and therefore were not reported [32, 48, 54]

31 articles [8–11, 16–23, 25–28, 30–32, 34, 35, 43–45, 48–50, 52, 54, 55, 57]

Severe or marked hypoglycaemic events

Reported threshold for defining a BGL as severe hypoglycaemic event:

• <40 [15, 20, 25, 29, 33, 42, 46, 47, 51, 56];

• ≤ 40 [12, 13, 16];

• <48 [24]; or

• in one study clinical finding defined as severe hypoglycaemia [8]

Represented as:

• percentage and number of measurements and/or patients with severe hypoglycaemic event;

• mean or median of events per patient-day [29];

• In two studies severe hypoglycaemic events did not occur and therefore not reported [47, 56]

15 articles [8, 12, 13, 15, 16, 20, 24, 25, 29, 33, 42, 46, 47, 51, 56]

Need for dextrose injection

Reported threshold for dextrose injection:

• <45 [29];

• <54 [44];

• <60 [53];

• <63 [23];

• <65 [25]; or

• threshold was not reported [21, 56]

Represented as:

• percentage and number of patient with dextrose injection [21, 23, 29, 44, 53, 56]; or

• percentage and number of dextrose injections [25]

7 articles [21, 23, 25, 29, 44, 53, 56]

Mild or moderate hypoglycaemic events

Reported threshold for defining an BGL as severe hypoglycaemic event:

• 40–59 [42];

• <60 [46];

• 40–60 [51];

• <63 [15]

Represented as percentage and number of measurements and/or patients with a moderate hypoglycaemic event

4 articles [15, 42, 46, 51]

Hypoglycaemia duration

Represented cumulatively [29], as median [24] and per patient [21]

3 articles [21, 24, 29]

Time until next in predefined range after hypoglycaemia

Represent as mean [8, 49] or median [31] time

3 articles [8, 31, 49]

Duration of stopping IIT because of hypoglycaemia

Represented as median of percentage of time per patient

2 articles [29, 33]

Next BGL after hypoglycaemia

Represented as mean BGL

2 articles [8, 49]

Time until reaction to hypoglycaemic event

Represented as maximum time till hypoglycaemia recognition [8] or mean time till IIT adjustment after hypoglycaemic event [28]

2 articles [8, 28]

Time from starting IIT until first hypoglycaemia

Represented as mean time

1 article [19]

Time till next BGL after hypoglycaemia

Represented as mean time

1 article [49]