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Completed

NCT Number: NCT02306681

A Survey on Low Blod Sugar Among Insulin-treated Patients With Diabetes

This study is conducted globally. The aim of this study is to describe the proportion of patients with hypoglycaemic episodes and estimate the incidence of various types of hypoglycaemia in the retrospective and prospective periods.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Dhaka, Bangladesh

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent obtained before any trial-related activities
  • Patient with T1DM or T2DM treated with insulin for more than 12 months
  • Male or female patient at least 18 years of age at the time of inclusion in the study

Exclusion criteria

  • Previous participation in this study
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Illiterate patients and patients otherwise unable to sign the Informed Consent or complete a written survey
  • Non-ambulatory patients
  • Simultaneous participation in any other clinical study with an investigational product

Treatment and study plan

No treatment given

Other

This study comprises of a two-part SAQ (Self-Assessment Questionnaire). Paired responses to SAQ1 and SAQ2 will be used to estimate the differences in the frequency of hypoglycaemic episodes between the retrospective and prospective periods.

Primary outcomes

  1. The percentage of patients who experience at least 1 hypoglycaemic episode

    Time frame: During the 4-week prospective observational period

Secondary outcomes

  1. Incidence of any hypoglycaemic episodes

    Time frame: In the 4 weeks before and 4 weeks after the baseline (day 1)

  2. Incidence of hypoglycaemic episodes requiring hospital admission

    Time frame: In the 6 months before and 4 weeks after the baseline (day 1)

  3. Incidence of severe hypoglycaemic episodes

    Time frame: In the 6 months before and 4 weeks after the baseline (day 1)

  4. Incidence of non-severe hypoglycaemic episodes

    Time frame: In the 4 weeks before and 4 weeks after the baseline (day 1)

  5. Incidence of documented symptomatic hypoglycaemic episodes

    Time frame: In the 4 weeks after the baseline visit (day 1)

  6. Incidence of all hypoglycaemic episodes associated with a blood glucose measurement below 3.1 mmol/L (56 mg/dl) irrespective of symptoms

    Time frame: In the 4 weeks following the baseline visit (day 1)

  7. Incidence of hypoglycaemic episodes

    Time frame: Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1)

  8. Incidence of probable symptomatic hypoglycaemia

    Time frame: In the 4 weeks following the baseline visit (day 1)

  9. Frequency of blood glucose monitoring

    Time frame: Over 1 day

  10. Patient reported fear of hypoglycaemia

    Time frame: Over one day

  11. Patient reported recovery times

    Time frame: One day

  12. Proportion of patients consulting a doctor

    Time frame: Over one day

  13. Proportion of patients increasing calorie intake

    Time frame: Over one day

  14. Proportion of patients avoiding physical exercise

    Time frame: Over one day

  15. Proportion of patients reducing or skipping insulin dose

    Time frame: Over one day

  16. Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes

    Time frame: Over one day

  17. Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes

    Time frame: Over one day

  18. DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores

    Time frame: Over last 4 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2014
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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