NCT02632032

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

1 month

First QC Date

December 4, 2015

Last Update Submit

December 15, 2015

Conditions

Keywords

Type 1 diabeteschildrendiabetes campsglycemic control

Outcome Measures

Primary Outcomes (1)

  • Changes in HbA1c

    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 Outcomes (3)

  • Changes in insulin doses

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

  • Hypoglycemic episode per camper per day

    From the first day to the third day of camp

  • Changes in weight

    Baseline to 3 months and 12 months after camp

Study Arms (1)

Insulin therapy and diabetes education

OTHER

Children and adolescents living with type 1 diabetes already on insulin therapy received collective diabetes education during a five days camp.

Drug: Insulin

Interventions

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

Also known as: regular, NPH and premixed insulin
Insulin therapy and diabetes education

Eligibility Criteria

Age6 Years - 23 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Mesmin Y Dehayem, MD

    Yaounde Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant internist and endocrinologist, Yaounde Central Hospital

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 16, 2015

Study Start

July 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2014

Last Updated

December 17, 2015

Record last verified: 2015-12