For the HypoDE study people with type 1 diabetes treated by MDI with a high risk of hypoglycemic events were recruited. Baseline data of 126 study participants were analyzed (age 46.5±11.6 yrs., 36.5% female, HbA1c 7.5±1.0%). They reported 4.5±9.2 episodes of severe hypoglycemia per year (third party assistance for recovery required) and 1.0±2.4 episodes of hypoglycemic episodes with coma or seizure per year prior to study participation. This corresponds to 700%, respectively 600% more hypoglycemic episodes than observed in the DCCT 0.64,respectively 0.16 episodes per year). Blinded CGM recordings for 28 days during the run-in phase of the study revealed that the participants had 12.7±11.8 hypoglycemic events per 28 days (= glucose reading ≤55 mg/dl for at least 20 min). They spent 109 min per day at glucose levels ≤70 mg/dl and 34 min per day ≤50 mg/dl. This corresponds to 32.5%, respectively 55% more time in this range that the adult participants in the JDRF CGM-trial. The hypoglycemia unawareness score of the participants was 5.0±1.1 (out of a maximum score of 7); 95.2% yielded a score ≥4, which is used as a cut-off score for hypoglycemia unawareness. In the Hypoglycemia Fear Survey, HypoDE participants achieved a score of 32.3±15.5 and a Diabetes Distress Scale mean item score of 2.5±1.2. Both scores were higher than those which could be expected in a sample of people with type 1 diabetes, not specifically selected by hypoglycemia problems.
In summary, these data suggest that HypoDE participants represent patients with a high risk of clinical as well as biochemical hypoglycemic events. Compared to the “typical” patient with type 1 diabetes, these subjects reported a high amount of hypoglycemia worries and diabetes-related distress.