- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02632032
Impact of a Diabetes Camp on Glycemic Control Among Children and Adolescents Living With Type 1 Diabetes in Cameroon
Study Overview
Detailed Description
Participants and setting:
In this study, the investigators analyzed the data of children and adolescents living with type 1 diabetes in Cameroon who attended the diabetes camp organized in Yaoundé in July 2013 and who came back for follow up at the CDiC clinic of the Yaoundé Central Hospital, 3 and 12 months later.
The "Changing Diabetes in Children" (CDiC) project offers logistics and free medical care to children living with type 1 diabetes in Cameroon, which includes free medical consultations, insulin, syringes, a glucose meter (Accu Check Active®, Roche Diagnostics GmbH, Mannheim, Germany) glucose strips, HbA1c monitoring every 3 months, collective therapeutic education sessions every 3 months and a yearly screening for complications. All children enrolled in the project have a systematic visit every three months. During this visit, clinical and biological assessment are done, also adjustment of treatment, therapeutic education and record of data in the medical record. Many children also consult outside systematic visits to collect the material for treatment or in case of an emergency related or not with diabetes. The forms of insulin available in the project are regular insulin (Actrapid®), intermediate-acting insulin (Insulatard®) and pre-mixed insulin (Mixtard 30®). HbA1c is assessed by the in2it™ point-of-care system (Bio-Rad Laboratories, Deeside, UK).
The CDiC program organizes a 5-day camp for about 50 children twice yearly. Participants are selected by the health care personnel who follow them, based on the availability of places and on the proximity to their homes. Children of less than 6 years old, those with an acute disease and those with incomplete recovery from a previous illness are not allowed to camp.
Camp organization:
A written informed consent was obtained from parents or guardians before inclusion and a medical insurance was contracted for campers and the camp staff. The camp staff was made of a pediatric endocrinologist, an adult endocrinologist, 3 general physicians, 4 nurses, a dietician and a sport coach. The leisure program during the camp included education workshops, games, sporting activities, a visit to an animal reserve and a dinner in a restaurant in town. Meals offered to the children attending the camp were prepared following the instructions of the dietician.
Treatment protocols and insulin doses of each camper were maintained upon arrival. However, during the camp and before every meal, the dose of insulin to be injected was analyzed and eventually modified by the physician based on the results of self-monitoring of blood glucose, the quantity of carbohydrates to be ingested, and the level of physical activity to be performed. Notwithstanding, the treatment protocols could still be modified for some camper who were poorly controlled.
At the end of camp, a prescription was done for every campers and an adjustment of doses was made based on capillary glucose. Capillary glucose was measured six times a day (Before and 2 hours after the 3 main daily meals), and as needed (Before and after an intense physical activity, and in case of a symptoms suggestive of hypoglycemia). Finally, all information on each camper (injected insulin doses, capillary blood glucose, HbA1c, weight and eventual malaise) were recorded in a self-monitoring booklet by the camper always under supervision of a camp staff.
Post-camp data collection Campers were later on routinely followed at the CDiC clinic of the Yaoundé Central Hospital. Of the 46 patients who attended the camp, only 32 who came for follow up 3 and 12 months later were included in further analyses. Data on age, gender, duration of diabetes, duration of follow up in the CDiC project, weight, insulin regimen and insulin doses at the beginning, at 3 and 12 months after camp, HbA1c at the beginning, at 3 and at 12 months after camp, and the daily number hypoglycemic episodes during camp were collected. Good glycemic control was defined as HbA1c <7.5% and hypoglycemia as capillary glucose < 70mg/dl.
Data analysis Data were analyzed using the Statistical Package for Social Sciences version 12 (SPSS Inc. Chicago, IL USA). Results are presented as mean and standard deviation or median [interquartile range] for continuous variables and as count (percentage) for discrete variables. Proportions were compared by the Z test for two proportions, means by repeated measure ANOVA, paired t test or independent t test where appropriate and medians by the Wilcoxon rank sum test. Where necessary continuous variables were categorized using the median as cutoff. A p-value < 0.05 was used to characterize statistically significant results.
Ethical considerations Prior to enrolment in the CDiC project, a written informed consent form was signed by the parent or guardian authorizing the CDiC project in Cameroon to use the data obtained for research. A written informed consent was also obtained from parents or guardians before enrolment in camp. The CDiC project has also received approval from the National Ethics Committee of Cameroon (Autorisation N 271/CNE/SE/2011) to carry out research from data obtained in the project.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
Monitoring insulin therapy of campers based on their usual regimen (one of the following):
Education of campers on different aspects of diabetes care:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline to 3 months and 12 months after camp
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From the first day to the third day of camp, 3 months and 12 months after camp
|
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
|
From the first day to the third day of camp
|
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
|
Baseline to 3 months and 12 months after camp
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mesmin Y Dehayem, MD, Yaoundé Central Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDiC-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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