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
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Insulin||Not Applicable|
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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.
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 :||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|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2014|
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 Name: regular, NPH and premixed insulin
- 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
- 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
- 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
- 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
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
|Principal Investigator:||Mesmin Y Dehayem, MD||Yaounde Central Hospital|