To Estimate the Percentage of Children and Adolescents in Tunisia With Acceptably Controlled Diabetes Mellitus Type 1
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01493388
First received: December 14, 2011
Last updated: August 17, 2012
Last verified: August 2012
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Purpose
This study is conducted in Africa. The aim of this study is to estimate the percentage of children and adolescents below or equal to 15 years in Tunisia with acceptably controlled diabetes mellitus type 1.
| Condition | Intervention |
|---|---|
|
Diabetes Diabetes Mellitus, Type 1 |
Other: No treatment given |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Observational, Cross-sectional and Retrospective Study on Diabetes Mellitus Type 1 in Tunisian Children and Adolescents Under 15 Years |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Percentage of children below 6 years with HbA1c less than 8.5% [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Percentage of children between 6-12 years with HbA1c less than 8% [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Percentage of adolescents between 13 and 15 years with HbA1c less than 7.5% [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fasting plasma glucose (FPG) level [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Blood pressure level in children 12 years or older [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Total cholesterol and LDL-cholesterol levels in children 12 years or older [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Percentage of children with evaluation of thyroid function within the last 2 years [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Percentage of children with nephropathy [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Percentage of children with microalbuminuria [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Percentage of children with hypoglycemia event having led to hospitalization [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Percentage of children with self-monitoring of blood-glucose [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Percentage of parents and children having received at least one training and topic of the received training [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
- Type and dose of insulin treatment [ Time Frame: one assessment during a 5 month period is made, by review of the patient's medical records and/or interview (only 1) ] [ Designated as safety issue: No ]
| Enrollment: | 402 |
| Study Start Date: | March 2012 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| A |
Other: No treatment given
Patients will be treated according to routine clinical practice at the discretion of the treating physician.
|
Eligibility| Ages Eligible for Study: | up to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients will be treated according to routine clinical practice at the discretion of the treating physician.
Criteria
Inclusion Criteria:
- Written informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol).
- Child or adolescent below or equal to 15 years with diabetes mellitus type 1
- Who has been undergoing treatment for diabetes for at least 6 months
Exclusion Criteria:
- Previous participation in this study.
- Current participation to a clinical trial
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01493388 History of Changes |
| Other Study ID Numbers: | INS-3914, U1111-1124-9862 |
| Study First Received: | December 14, 2011 |
| Last Updated: | August 17, 2012 |
| Health Authority: | Tunisia: Ministry of Public Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013