The purpose of this observational study is to investigate the adherence during 2 months in adolescents with type 1 diabetes on subcutaneous insulin pump therapy. The main outcome measure will be the amount of insulin bolusses and glucose…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study the bolus frequency, the SMBG frequency, their interaction and influence
on hba1c value in a group of adolescents with diabetes type 1 during the two
months prior to a regular outpatient clinic visit
Secondary outcome
1. Is there a relationship between the SMBG-frequency and the bolus frequency.
2. Is one particular bolus most skipped (breakfast, lunch, dinner)
3. Is there a relationship between the SMBG-frequency and age.
4. Is there a relationship between the SMBG-frequency and diabetes duration.
5. Is there a relationship between the SMBG-frequency and gender.
6. Is there a relationship between the SMBG-frequency and the HbA1c.
7. Is there a relationship between the bolus frequency and age.
8. Is there a relationship between the bolus frequency and diabetes duration.
9. Is there a relationship between the bolus rate and gender.
10. Is there a relationship between the bolus frequency and HbA1c
11.What factors determine in particular the height of the Hba1c:
SMBG-frequency, bolus frequency, age, gender, diabetes duration, family
composition, level of education parents/adolescent, alcohol/smoking/drug use,
exercise?
12. what factors determine in particular the bolus frequency: SMBG-frequency,
age, gender, diabetes duration, family composition, level of education
parents/adolescent, alcohol/smoking/drug use, exercise?
13. what factors determine in particular the SMBG-frequency: bolus frequency,
age, sex, duration of puberty, diabetes, educational level parents/adolescent,
alcohol/smoking/drug use, exercise?
14. Is there a relationship between the use of the boluswizzard and the HbA1c
levels.
15. Is there diabetes related stress by their parents and/or adolescent?
16. Is there diabetes related conflicts within the family?
17. How is the quality of life among our adolescents with diabetes?
Background summary
Adolescents often have trouble regulating their diabetes well. This concerns
both the regular blood glucose measurements as the calculation and proper
dosing of insulin bolusses. International studies so far show the cause for
this poor adherence is multifactorial. . Psychosocial factors such as anxiety
and depression, often occuring in adolescents with diabetes, relatively poor
coping mechanisms and problem solving ability and hormonal changes during
puberty may play a role. Optimal regulation is of great importance for the
prevention of complications and early mortality. Furthermore reduction of
complications will reduce health care costs. Until now there is no research
done in the Netherlands, concerning adherence and its determinants in
adolescents with diabetes. So it is unknown whether the factors that play a
role in adherance in international studies also apply to adolescents with dm1
in the the Netherlands.
Study objective
The purpose of this observational study is to investigate the adherence during
2 months in adolescents with type 1 diabetes on subcutaneous insulin pump
therapy. The main outcome measure will be the amount of insulin bolusses and
glucose measurements this will be compared with the "gold standard" (optimal
diabetes management): at least 4 blood glucose measurements per day (i.e. for
each meal and for the night). The ultimate goal is to examine what patient
characteristics determine therapy adherence in adolescents with diabetes.
Study design
This is an observational study. During two months adherence in adolescents with
diabetes type 1 is measured by the number of blood glucose measurements and
mealtime insulin boluses given. Furthermore a questionnaire will be filled in
to measure factors determining stress and quality of life .Based on these data
, we want to design an intervention study with the aim to improve diabetic
control by improving therapy adherence. This study is carried out at the
Diabetes Centre Isala Clinics.
Study burden and risks
This study is conducted in children, because the study is aimed at improving
diabetes care in children,This study does not include any risk for
participating children and their parents and the load is minimal. The most
important contribution of the participants is to once fill in some
questionnaires taking maximum 1 hour. There is no risk for adverse serious
events. Filling in the questionnaires will take less than 40 minutse.
Dr van Heesweg 2
8025 AB Zwolle zwolle
NL
Dr van Heesweg 2
8025 AB Zwolle zwolle
NL
Listed location countries
Age
Inclusion criteria
Age 12 to 18 years.
Diabetes mellitus type 1, defined as, C-peptide levels <0.05 nmol / L at presentation and a glucose level> 7 mmol / L, positive autoantibodies, no evidence for MODY or type 2 diabetes.
>= 1 year type 1 diabetes.
>= 3 month subcutaneous insulin pump.
Exclusion criteria
mental retardation.
Inadequate knowledge of Dutch language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41428.075.12 |