Background
Methods
Study design
Study population
Assessments
Study objectives
Hypoglycemia classification
Sample size
Evaluability of patients for analysis
Statistical methods
Results
Patient characteristics
T1DM (N = 306) | T2DM (N = 2042) | |
---|---|---|
Age (years) | 32.7 (11.6) | 58.0 (10.5) |
Median | 30.5 | 58.0 |
Upper quartile, Lower quartile | 39.0, 24.0 | 65.0, 51.0 |
Male/female (%) | 44.1/55.9 | 40.9/59.1 |
Duration of diabetes (years) | 12.1 (8.0) | 12.5 (7.0) |
Median | 10.5 | 11.0 |
Upper quartile, lower quartile | 17.0, 6.0 | 17.0, 7.0 |
Duration of insulin use (years) | 11.2 (7.8) | 6.0 (4.6) |
Median | 10.0 | 5.0 |
Upper quartile, lower quartile | 16.0, 5.0 | 8.0, 3.0 |
HbA1c (mmol/mol) | 67.9 (18.1) | 72.3 (20.4) |
HbA1c (%) | 8.4 (1.7) | 8.8 (1.9) |
FBG (mmol/L) | 8.6 (4.1) | 9.6 (4.0) |
FBG (mg/dL) | 155.0 | 173.0 |
PPG (mmol/L) | 11.1 (4.8) | 12.5 (4.9) |
PPG (mg/dL) | 200.0 (86.5) | 225.2 (88.3) |
Weight (kg) | 70.4 (16.2) | 83.7 (14.9) |
Median | 68.0 | 82.0 |
Upper quartile, lower quartile | 80.0, 60.0 | 92.0, 74.0 |
Height (cm) | 167.8 (10.0) | 164.2 (8.5) |
Median | 168.0 | 164.0 |
Upper quartile, lower quartile | 174.0, 160.0 | 170.0, 158.0 |
BMI (kg/m2) | 25.0 (5.2) | 31.2 (5.7) |
Median | 24.3 | 30.5 |
Upper quartile, lower quartile | 27.2, 21.8 | 34.0, 27.3 |
Previous medical illnesses | % of patients | % of patients |
Neuropathy | 34.6 | 53.1 |
Retinopathy | 20.6 | 39.6 |
Nephropathy | 9.2 | 14.6 |
Peripheral vascular disease | 14.7 | 20.2 |
Angina | 9.8 | 17.4 |
Myocardial infarction | 3.3 | 15.6 |
None | 49.0 | 27.7 |
Symptoms of diabetes-related complications, % | ||
Any | 98.4 | 95.4 |
Tremor | 84.0 | 80.5 |
Sweating | 85.6 | 79.4 |
Hunger | 83.0 | 78.2 |
Tiredness | 83.0 | 76.4 |
Weakness | 78.4 | 72.9 |
Diabetes treatment regimen, % | ||
Short-acting insulin | 12.1 | 5.5 |
Long-acting insulin | 4.6 | 17.3 |
Pre-mix | 4.2 | 33.3 |
Both short- and long-acting | 74.2 | 41.1 |
Both short-acting and pre-mix | 0.3 | 0.6 |
Both long-acting and pre-mix | 3.3 | 1.4 |
Short- and long-acting and pre-mix | 0.0 | 0.0 |
Missing | 1.3 | 0.8 |
Frequency of hypoglycemia
Any hypoglycemia
Nocturnal hypoglycemia
Severe hypoglycemia
Use of health system resources
T1DM | T2DM | |||
---|---|---|---|---|
Impact of hypoglycemic events on the medical system (%) | Retrospective (n = 306) | Prospective (n = 253) | Retrospective (n = 2042) | Prospective (n = 1796) |
Events requiring hospital admission | 10.2 | 3.3 | 6.1 | 1.9 |
Attended additional clinical appointments | 15.8 | 12.6 | 11.4 | 8.0 |
Made additional telephone contacts | 6.3 | 5.3 | 4.1 | 3.3 |
Patient response to hypoglycemia (%) | Retrospective (n = 306) | Prospective (n = 252) | Retrospective (n = 2042) | Prospective (n = 1781) |
Consulted their doctor/nurse | 47.4 | 32.9 | 39.3 | 32.6 |
Required any form of medical assistance | 48.7 | 33.3 | 41.0 | 32.6 |
Increased calorie intake | 35.3 | 28.6 | 27.6 | 17.6 |
Avoided physical exercise | 17.6 | 13.1 | 11.3 | 9.2 |
Reduced insulin dose | 35.0 | 18.7 | 18.8 | 13.0 |
Skipped insulin injections | 23.9 | 10.3 | 18.0 | 9.8 |
Increased blood glucose monitoring | 52.3 | 46.4 | 28.9 | 20.9 |
Impact of hypoglycemic events on work and study (%) | Retrospective (n = 200) | Prospective (n = 166) | Retrospective (n = 360) | Prospective (n = 321) |
Taken leave from work or studies | 22.0 | 6.6 | 10.8 | 3.1 |
Arrived late to work/studies | 24.5 | 9 | 6.4 | 2.5 |
Left early from work/studies | 20.5 | 11.4 | 10.8 | 2.5 |
T1DM (N = 306) | T2DM (N = 2042) | |||
Knew what hypoglycemia was at baseline before Part 1 SAQ (%) | ||||
91.3 | 60.4 | |||
Defined hypoglycemia based on (%) | ||||
Symptoms only | 54.6 | 52.4 | ||
Blood glucose measurement only | 2.3 | 3.5 | ||
Either | 15.4 | 15.2 | ||
Both | 24.2 | 18.8 | ||
Hypoglycemia awareness (%) | ||||
Normal | 71.6 | 53.3 | ||
Impaired | 25.2 | 38.5 | ||
Severely impaired | 0.7 | 2.8 | ||
Fear of hypoglycemia (Scale of 0 to 10; %) | ||||
0 = no fear | 19.9 | 24.3 | ||
1 | 3.9 | 5.9 | ||
2 | 2.3 | 5.8 | ||
3 | 5.6 | 5.4 | ||
4 | 5.6 | 4.6 | ||
5 | 13.1 | 10.7 | ||
6 | 6.5 | 6.6 | ||
7 | 9.8 | 9.9 | ||
8 | 10.1 | 8.7 | ||
9 | 5.2 | 4.6 | ||
10 = absolutely terrified | 17.3 | 12.2 |