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 13, 2014
Last verified: June 2014

September 26, 2012
June 13, 2014
September 2012
November 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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic events requiring hospital admission [ Time Frame: In the 6 months prior to and 4 weeks following the baseline visit ] [ Designated as safety issue: No ]
  • Incidence of all severe hypoglycaemic events [ Time Frame: In the 6 months prior to and 4 weeks following the baseline visit ] [ Designated as safety issue: No ]
  • Incidence of probable symptomatic hypoglycaemic events [ Time Frame: In the 4 weeks prior to and following the baseline visit ] [ Designated as safety issue: No ]
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23606
November 2013
November 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Bulgaria,   Canada,   Croatia,   Czech Republic,   Denmark,   Finland,   Germany,   Hungary,   India,   Israel,   Lebanon,   Malaysia,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   Slovenia,   Sweden
 
NCT01696266
INS-4019, U1111-1132-1910
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Angele Mongul Novo Nordisk A/S
Novo Nordisk A/S
June 2014

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