Related Experiment Video
Updated: Jun 19, 2026

Improving IV Insulin Administration in a Community Hospital
Published on: June 11, 2012
Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes
Tom Stargardt1, Linda Gonder-Frederick, Karl J Krobot
1Health Services Management, Munich School of Management, Munich University, Germany. Stargardt@bwl.lmu.de
Background:
To explore the concept of the Minimum Clinically Important Difference (MID) of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II) and to quantify the clinical importance of different types of patient-reported hypoglycaemia.
Methods:
An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM), and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia.
Results:
112 patients (28.6%) reported hypoglycaemic episodes, with 15 patients (3.8%) reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6) and without (12.1) need for assistance scored higher on the HFS-II (range 0 to 72) than patients who did not report hypoglycaemia (6.0).
Conclusion:
We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents.
Related Concept Videos
Hypoglycemia
Type II Diabetes Mellitus III: Clinical Manifestations and Diagnosis
Hypoglycemia and Glucagon
Type I Diabetes III: Clinical Manifestations
Hyperglycemia
Diabetes: Symptoms, Diagnosis, and Complications

