Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes.
Interventions
OTHERNo treatment given
Two different questionnaires will be applied to patients during a regular clinical visit.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any study-related activities * The following patients will be considered eligible for inclusion in the study: Patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months and patients at least 18 years of age at the time of the survey
Exclusion criteria
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * Illiterate patients and patients otherwise unable to 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 experiencing at least 1 hypoglycaemic event | During 4 weeks from baseline visit |
Secondary
| Measure | Time frame |
|---|---|
| Severe hypoglycaemic events | In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit |
| Non-severe hypoglycaemic events | In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit |
| Nocturnal hypoglycaemic events | In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit |
| Hypoglycaemic events requiring hospital admission | In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit |
| Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms | In the 4 weeks following the baseline visit (Patient Diary) |
| All hypoglycaemic events (any type) | In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit |
| Difference in the reported incidence rates of hypoglycaemia | In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit |
| Documented symptomatic hypoglycaemic events | In the 4 weeks following the baseline visit (Patient Diary) |
Countries
Brazil
Outcome results
None listed