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Type 1 DiabetesNCT02632032

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

A study testing Insulin in people with Type 1 Diabetes, run by Yaounde Central Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 23 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
Jul 2013to Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 23 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

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.

Read the 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.

Conditions
Type 1 Diabetes
Being tested
Insulin
Keywords
Type 1 diabetes, children, diabetes camps, glycemic control
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InsulinDrug

    Also called regular, NPH and premixed 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
Study groups in NCT02632032
Study groupRoleWhat they receive
Insulin therapy and diabetes educationOtherChildren and adolescents living with type 1 diabetes already on insulin therapy received collective diabetes education during a five days camp.
Receives: Drug: Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in HbA1c

    Comparing the mean HbA1c of campers from baseline to 3 months and 12 months after camp

    Measured: Baseline to 3 months and 12 months after camp

Secondary outcomes (3)
  1. Changes in insulin doses

    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

    Measured: From the first day to the third day of camp, 3 months and 12 months after camp

  2. Hypoglycemic episode per camper per day

    Comparing the mean number of hypoglycemic episode register per camper from the first day to the third day of camp

    Measured: From the first day to the third day of camp

  3. Changes in weight

    Comparing the mean weight of campers from baseline to 3 months and 12 months after camp

    Measured: Baseline to 3 months and 12 months after camp

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2015 (estimated)
  2. Study startJul 2013
  3. Primary completionAug 2013
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02632032
Sponsor's protocol ID
CDiC-01
Status last verified
Dec 2015
First submitted
4 Dec 2015
Last updated
17 Dec 2015
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    PubMed 26791079

Questions about this trial

What is this clinical trial studying?

A study testing Insulin in people with Type 1 Diabetes, run by Yaounde Central Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in HbA1c (time frame: Baseline to 3 months and 12 months after camp). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02632032, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.

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