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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):
Mesmin Dehayem Yefou, Yaounde Central Hospital

Tracking Information
First Submitted Date  ICMJE December 4, 2015
First Posted Date  ICMJE December 16, 2015
Last Update Posted Date December 17, 2015
Study Start Date  ICMJE July 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2015)
Changes in HbA1c [ Time Frame: 3 months and 12 months after camp ]
Comparing the mean HbA1c of campers from baseline to 3 months and 12 months after camp
Change History Complete list of historical versions of study NCT02632032 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2015)
  • Changes in insulin doses [ Time Frame: 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: 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: 3 and 12 months after camp ]
    Comparing the mean weight of campers from baseline to 3 months and 12 months after camp
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of a Diabetes Camp on Glycemic Control Among Children and Adolescents Living With Type 1 Diabetes in Cameroon
Official Title  ICMJE Impact of a Diabetes Camp on Glycemic Control Among Children and Adolescents Living With Type 1 Diabetes in Cameroon
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 <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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Insulin
Publications * Dehayem MY, Takogue R, Choukem SP, Donfack OT, Katte JC, Sap S, Sobngwi E, Mbanya JC. Impact of a pioneer diabetes camp experience on glycemic control among children and adolescents living with type 1 diabetes in sub-Saharan Africa. BMC Endocr Disord. 2016 Jan 20;16:5. doi: 10.1186/s12902-016-0086-x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2015)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 23 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02632032
Other Study ID Numbers  ICMJE CDiC-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mesmin Dehayem Yefou, Yaounde Central Hospital
Study Sponsor  ICMJE Yaounde Central Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mesmin Y Dehayem, MD Yaounde Central Hospital
PRS Account Yaounde Central Hospital
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP