Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted globally. The aim of this study is to describe the proportion of patients with hypoglycaemic episodes and estimate the incidence of various types of hypoglycaemia in the retrospective and prospective periods.
Interventions
OTHERNo treatment given
This study comprises of a two-part SAQ (Self-Assessment Questionnaire). Paired responses to SAQ1 and SAQ2 will be used to estimate the differences in the frequency of hypoglycaemic episodes between the retrospective and prospective periods.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities * Patient with T1DM or T2DM treated with insulin for more than 12 months * Male or female patient at least 18 years of age at the time of inclusion in the study
Exclusion criteria
* Previous participation in this study * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * Illiterate patients and patients otherwise unable to sign the Informed Consent or complete a written survey * Non-ambulatory patients * Simultaneous participation in any other clinical study with an investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients who experience at least 1 hypoglycaemic episode | During the 4-week prospective observational period |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of hypoglycaemic episodes requiring hospital admission | In the 6 months before and 4 weeks after the baseline (day 1) |
| Incidence of severe hypoglycaemic episodes | In the 6 months before and 4 weeks after the baseline (day 1) |
| Incidence of non-severe hypoglycaemic episodes | In the 4 weeks before and 4 weeks after the baseline (day 1) |
| Incidence of documented symptomatic hypoglycaemic episodes | In the 4 weeks after the baseline visit (day 1) |
| Incidence of all hypoglycaemic episodes associated with a blood glucose measurement below 3.1 mmol/L (56 mg/dl) irrespective of symptoms | In the 4 weeks following the baseline visit (day 1) |
| Incidence of hypoglycaemic episodes | Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1) |
| Incidence of probable symptomatic hypoglycaemia | In the 4 weeks following the baseline visit (day 1) |
| Frequency of blood glucose monitoring | Over 1 day |
| Incidence of any hypoglycaemic episodes | In the 4 weeks before and 4 weeks after the baseline (day 1) |
| Patient reported recovery times | One day |
| Proportion of patients consulting a doctor | Over one day |
| Proportion of patients increasing calorie intake | Over one day |
| Proportion of patients avoiding physical exercise | Over one day |
| Proportion of patients reducing or skipping insulin dose | Over one day |
| Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes | Over one day |
| Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes | Over one day |
| DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores | Over last 4 weeks |
| Patient reported fear of hypoglycaemia | Over one day |
Countries
Bangladesh, Colombia, Egypt, Philippines, Singapore, South Africa, Turkey (Türkiye), United Arab Emirates
Outcome results
None listed