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Trial record 27 of 2791 for:    Type 1 Diabetes

Impact of a Diabetes Camp on Glycemic Control Among Children and Adolescents Living With Type 1 Diabetes in Cameroon

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ClinicalTrials.gov Identifier: NCT02632032
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Therapeutic education is central to the management of diabetes, especially in children and adolescents. Camps represent an ideal environment for education. During camps, the campers receive both theoretical and practical information intended to improve their understanding and self-management of diabetes. The metabolic impact of diabetes camp is little known among children and adolescents living with type 1 diabetes in sub-Saharan Africa. The aimed of this study was to assess the changes in glycemic control and insulin doses in a group of children and adolescents living with type 1 diabetes in Cameroon during and after camp.

Condition or disease Intervention/treatment
Type 1 Diabetes Drug: Insulin

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Impact of a Diabetes Camp on Glycemic Control Among Children and Adolescents Living With Type 1 Diabetes in Cameroon
Study Start Date : July 2013
Primary Completion Date : August 2013
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Insulin therapy and diabetes education
Children and adolescents living with type 1 diabetes already on insulin therapy received collective diabetes education during a five days camp.
Drug: Insulin

Monitoring insulin therapy of campers based on their usual regimen (one of the following):

  • premixed insulin in the morning and evening,
  • premixed insulin in the morning, regular insulin in the afternoon and premixed insulin in the evening,
  • regular insulin in the morning and afternoon, and premixed insulin in the evening.

Education of campers on different aspects of diabetes care:

  • monitoring of blood glucose
  • injection of insulin
  • adaptation of insulin doses according to blood glucose and during exercise
  • correction of hypoglycemia
  • dietary advice
Other Name: regular, NPH and premixed insulin


Outcome Measures

Primary Outcome Measures :
  1. Changes in HbA1c [ Time Frame: Baseline to 3 months and 12 months after camp ]
    Comparing the mean HbA1c of campers from baseline to 3 months and 12 months after camp


Secondary Outcome Measures :
  1. Changes in insulin doses [ Time Frame: From the first day to the third day of camp, 3 months and 12 months after camp ]
    Comparing the mean daily insulin doses of campers from the first day to the third day of camp, and 3 months and 12 months after camp

  2. Hypoglycemic episode per camper per day [ Time Frame: From the first day to the third day of camp ]
    Comparing the mean number of hypoglycemic episode register per camper from the first day to the third day of camp

  3. Changes in weight [ Time Frame: Baseline to 3 months and 12 months after camp ]
    Comparing the mean weight of campers from baseline to 3 months and 12 months after camp


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children living with type 1 diabetes and enrolled in the "Changing Diabetes in Children project".
  • Regular follow-up at the Yaoundé Central Hospital.
  • Aged between 6 and 23 years old.
  • Informed consent signed by parents or guardians prior to enrollment in the CDiC project allowing investigators of the project to used data for research.
  • Informed consent forms signed by parents or guardians before participation to the 2013 camp in Yaoundé.

Exclusion Criteria:

  • Nonattendance of the routinely follow-up visits at the CDiC clinic Yaoundé both at 3 and 12 months after camp.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632032


Sponsors and Collaborators
Yaounde Central Hospital
Investigators
Principal Investigator: Mesmin Y Dehayem, MD Yaounde Central Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mesmin Dehayem Yefou, Consultant internist and endocrinologist, Yaounde Central Hospital, Yaounde Central Hospital
ClinicalTrials.gov Identifier: NCT02632032     History of Changes
Other Study ID Numbers: CDiC-01
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mesmin Dehayem Yefou, Yaounde Central Hospital:
Type 1 diabetes
children
diabetes camps
glycemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs