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

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes
• Interventions: Other: No treatment given

• Registration Number: NCT02306681
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-30
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-03
• Primary Completion: 2015-05-14
• Study Completion: 2015-05-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7315

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SAQ-Self-Assessment Questionnaire	No treatment given	-

Primary Outcome Measures

Name	Time	Method
The percentage of patients who experience at least 1 hypoglycaemic episode	During the 4-week prospective observational period

Secondary Outcome Measures

Name	Time	Method
Incidence of probable symptomatic hypoglycaemia	In the 4 weeks following the baseline visit (day 1)
Proportion of patients consulting a doctor	Over one day
Incidence of documented symptomatic hypoglycaemic episodes	In the 4 weeks after the baseline visit (day 1)
Patient reported fear of hypoglycaemia	Over one day
Incidence of hypoglycaemic episodes requiring hospital admission	In the 6 months before and 4 weeks after the baseline (day 1)
Frequency of blood glucose monitoring	Over 1 day
Patient reported recovery times	One day
Proportion of patients increasing calorie intake	Over one day
Proportion of patients avoiding physical exercise	Over one day
Proportion of patients reducing or skipping insulin dose	Over one day
Incidence of severe hypoglycaemic episodes	In the 6 months before and 4 weeks after the baseline (day 1)
Incidence of any hypoglycaemic episodes	In the 4 weeks before and 4 weeks after the baseline (day 1)
Incidence of all hypoglycaemic episodes associated with a blood glucose measurement below 3.1 mmol/L (56 mg/dl) irrespective of symptoms	In the 4 weeks following the baseline visit (day 1)
Incidence of hypoglycaemic episodes	Between midnight and 6 a.m. in the 4 weeks before and 4 weeks after the baseline visit (day 1)
Proportion of patients increasing the number of blood glucose monitoring as a result of fear of hypoglycaemia or hypoglycaemic episodes	Over one day
Proportion of patients taking any sick leave, sick days or short days as a result of hypoglycaemic episodes	Over one day
DSQOLS (Diabetes-Specific Quality-of-Life Scale) scores	Over last 4 weeks
Incidence of non-severe hypoglycaemic episodes	In the 4 weeks before and 4 weeks after the baseline (day 1)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇪 Ajman, United Arab Emirates