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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1131-8540 | Other Identifier | WHO |
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This non-interventional study is conducted in Europe. The study is both retrospective and prospective.
The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with diabetes (type 1 and 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin | Drug | Patients will be asked to complete 2 self-assessment questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe) | During the one-month follow-up after inclusion in study |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia | During the last 12 months before inclusion in study | |
| Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia | During the one-month follow-up after inclusion in study |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 3811 patients with Type 1 or Type 2 diabetes are expected to be recruited. Patients will be asked to complete 2 self-assessment questionnaires, one retrospective and one prospective, to characterize severe hypoglycaemias during the last 12 months (retrospective questionnaire) and severe/non-severe hypoglycaemias during the coming month after inclusion (prospective questionnaire).
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Paris La Défense Cedex | 92932 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25465273 | Result | Cariou B, Fontaine P, Eschwege E, Lievre M, Gouet D, Huet D, Madani S, Lavigne S, Charbonnel B. Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: results from the DIALOG study. Diabetes Metab. 2015 Apr;41(2):116-25. doi: 10.1016/j.diabet.2014.10.007. Epub 2014 Nov 24. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia | During the one-month follow-up after inclusion in study |
| Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia | During the one-month follow-up after inclusion in study |
| Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe) | During the one-month follow-up after inclusion in study |
| Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia | During the last 12 months before inclusion in study |
| Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia | During the one-month follow-up after inclusion in study |
| Rate of episodes (event/patient/month) in insulin-treated patients of non-severe symptomatic hypoglycaemia episodes | During the one-month follow-up after inclusion in study |
| Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes | During the one-month follow-up after inclusion in study |
| Overall/severe/non-severe hypoglycaemia episodes (event/patient/month) | During the one-month follow-up after inclusion in study |
| Extra diagnostic tests carried out (number of extra self-monitoring plasma glucose (SMPG) test following the episode) | During the one-month follow-up after inclusion in study |
| Additional consultations to a specialist and/or general practitioner (GP), visit to emergency department, hospitalizations, transportation and assistance of a care-giver | During the one-month follow-up after inclusion in study |
| Change in planned daily activities; sleep, food consumption, physical activities (sport), driving, social life | During the one-month follow-up after inclusion in study |
| Change in planned daily activities; work: effectiveness, missing hours or days for sick leave | During the one-month follow-up after inclusion in study |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |