Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02632032
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2015-12-04
Brief Title:
Impact of a Diabetes Camp on Glycemic Control Among Children and Adolescents Living With Type 1 Diabetes in Cameroon
Sponsor:
Yaounde Central Hospital
Organization:
Yaounde Central Hospital
Study Overview
Official Title:
Impact of a Diabetes Camp on Glycemic Control Among Children and Adolescents Living With Type 1 Diabetes in Cameroon
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 75 and hypoglycemia as capillary glucose 70mgdl
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 005 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 271CNESE2011 to carry out research from data obtained in the project
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 75 and hypoglycemia as capillary glucose 70mgdl
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 005 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 271CNESE2011 to carry out research from data obtained in the project
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None