Clinical trial NCT02230631: A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Official title: A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 704
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty-five sites will be selected, distributed in different regions of the country, in order to be representative of the Brazilian population.

Brief summary: This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes.


Eligibility criteria: 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

Primary outcomes:
measure: The percentage of patients experiencing at least 1 hypoglycaemic event
timeFrame: During 4 weeks from baseline visit
Secondary outcomes:
measure: Hypoglycaemic events requiring hospital admission
timeFrame: In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit
measure: Severe hypoglycaemic events
timeFrame: In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
measure: Non-severe hypoglycaemic events
timeFrame: In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
measure: Nocturnal hypoglycaemic events
timeFrame: In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit
measure: Documented symptomatic hypoglycaemic events
timeFrame: In the 4 weeks following the baseline visit (Patient Diary)
measure: Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms
timeFrame: In the 4 weeks following the baseline visit (Patient Diary)
measure: All hypoglycaemic events (any type)
timeFrame: In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
measure: Difference in the reported incidence rates of hypoglycaemia
timeFrame: In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit
Other outcomes:
Locations:
city: Säo Paulo
country: Brazil
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: