A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Study Overview
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Brief Summary
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This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes.

Official Title
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A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: No treatment given


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before any study-related activities The following patients will be considered eligible for inclusion in the study: Patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months and patients at least 18 years of age at the time of the survey Exclusion Criteria: Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation Illiterate patients and patients otherwise unable to complete a written survey Non-ambulatory patients Simultaneous participation in any other clinical study with an investigational product

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Part 1 (retrospective cross-sectional evaluation)<br> | Other: No treatment given<br>* Two different questionnaires will be applied to patients during a regular clinical visit.<br>|
| Part 2 (prospective observational evaluation)<br> | Other: No treatment given<br>* Two different questionnaires will be applied to patients during a regular clinical visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients experiencing at least 1 hypoglycaemic event |  | During 4 weeks from baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycaemic events requiring hospital admission |  | In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit | 
| Severe hypoglycaemic events |  | In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit | 
| Non-severe hypoglycaemic events |  | In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit | 
| Nocturnal hypoglycaemic events |  | In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit | 
| Documented symptomatic hypoglycaemic events |  | In the 4 weeks following the baseline visit (Patient Diary) | 
| Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms |  | In the 4 weeks following the baseline visit (Patient Diary) | 
| All hypoglycaemic events (any type) |  | In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit | 
| Difference in the reported incidence rates of hypoglycaemia |  | In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit |