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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: September 6, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of any hypoglycaemic event [ Time Frame: In the 4 weeks prior to and following the baseline visit (Week 0) ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 29304
Actual Study Start Date: September 5, 2012
Study Completion Date: December 30, 2013
Primary Completion Date: December 30, 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Insulin-treated patients with diabetes 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).

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696266

  Show 24 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01696266     History of Changes
Other Study ID Numbers: INS-4019
U1111-1132-1910 ( Other Identifier: WHO )
Study First Received: September 26, 2012
Last Updated: September 6, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017