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To Estimate the Percentage of Children and Adolescents in Tunisia With Acceptably Controlled Diabetes Mellitus Type 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01493388
First received: December 14, 2011
Last updated: April 29, 2014
Last verified: April 2014
  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
Drug: insulin

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 A/S:

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 Drug: insulin
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493388

Locations
Tunisia
Tunisia, Tunisia, 1053
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01493388     History of Changes
Other Study ID Numbers: INS-3914, U1111-1124-9862
Study First Received: December 14, 2011
Last Updated: April 29, 2014
Health Authority: Tunisia: Ministry of Public Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014