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An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01696266
First received: September 26, 2012
Last updated: June 21, 2017
Last verified: June 2017
September 26, 2012
June 21, 2017
September 5, 2012
December 30, 2013   (Final data collection date for primary outcome measure)
Incidence of any hypoglycaemic event [ Time Frame: In the 4 weeks prior to and following the baseline visit (Week 0) ]
Same as current
Complete list of historical versions of study NCT01696266 on ClinicalTrials.gov Archive Site
  • Difference in the reported incidence rates of any hypoglycaemia [ Time Frame: In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit ]
  • Incidence of hypoglycaemic events requiring hospital admission [ Time Frame: In the 6 months prior to and 4 weeks following the baseline visit ]
  • Incidence of all severe hypoglycaemic events [ Time Frame: In the 6 months prior to and 4 weeks following the baseline visit ]
  • Incidence of probable symptomatic hypoglycaemic events [ Time Frame: In the 4 weeks prior to and following the baseline visit ]
Same as current
Not Provided
Not Provided
 
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
This study is conducted in Europe. The aim of the study is to gather information about hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The study is both retrospective and prospective.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Insulin-treated patients with Type 1 or Type 2 diabetes mellitus. Patients should be ambulatory, literate, have used insulin for at least 12 months, and be over 18 years of age to be able to participate in the study.
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Other: No treatment given
Patients will be asked to complete a two-part patient self-assessment questionnaire (SAQ) comprising a retrospective cross-sectional evaluation (Part 1), and a prospective observational evaluation (Part 2).
Insulin-treated patients with diabetes
Intervention: Other: No treatment given

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29304
December 30, 2013
December 30, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Type 1 or Type 2 diabetes mellitus treated with insulin for more than 12 months
  • Patients giving informed consent to participate in the survey

Exclusion Criteria:

  • Non-ambulatory patients
  • Illiterate patients and patients otherwise unable to complete a written survey
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Bulgaria,   Canada,   Croatia,   Czechia,   Denmark,   Finland,   Germany,   Hungary,   India,   Israel,   Lebanon,   Malaysia,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   Slovenia,   Sweden
Czech Republic
 
NCT01696266
INS-4019
U1111-1132-1910 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP