Status:Active, not recruiting
Keywords:Type 1 Diabetes
IRB Number:00056717
Specialty:
Sub Specialty:
Primary objective
Evaluation of the percentage of T1DM patients with controlled glycemia reflected by HbA1 c
at targets* according to guidelines (1) (2) in predefined age groups** (3).
The assessment of this primary objective is based on country or region (e.g. group of
countries) data analyses; the analysis of the global population will be supportive.
* HbA1 c < 7.5 % for patients < 18 years old (ISPAD) and HbA1 c < 7% for patients ≥ 18 years old (ADA).
** [8-12], [13-18] and [19-25] years based on the PedsQL group of age evaluation.
Secondary objectives
1. Quality of life (QOL) of T1DM patients evaluated with PedsQL questionnaires (to be
completed by patients and parents/guardian) in the different
predefined age classes (subgroup analysis with controlled and uncontrolled patients).
2. Evaluation of the emotional status using the PAID (Problem Areas In Diabetes)
questionnaire for patients aged 13 to 25 years old and PAID-PR questionnaire
for parents.
3. Association between main objectives (i.e. glycemic control and QOL) and patient’s
characteristics, treatment, structure and process of care in the different predefined age
groups.
Principle Investigator: Vandana Raman
Principle Department: Pediatric Administration
Co Investigator:
Name:Karen Wheeler
Phone:801-587-3944
Email:Karen.Wheeler@hsc.utah.edu
Inclusion Criteria:
1. Patients aged 8 to 25 years old, diagnosed at least 1 year prior to the study entry with type-1 diabetes mellitus.
2. Signed written informed consent obtained from the patient if applicable or from the parent(s)/guardian.
Exclusion Criteria:
1. T1DM diagnosed after 18 years of age for patients >18 years old.
2. Diabetes other than type-1 diabetes (e.g. type-2 diabetes, secondary
diabetes mellitus (pancreatic history, drug- or chemical-induced
diabetes), genetic defects in β-cell function or insulin action).
3. Use of systemic glucocorticoids (excluding topical application or
inhaled forms) for 7 consecutive days or more within the last 3
months.
4. Patients with known uncontrolled or inadequately controlled
hyperthyroidism or hypothyroidism.
5. Change from pump regimen to multiple insulin injections regimen
within the last 3 months.
6. Change from multiple insulin injections regimen to pump regimen
within the last 3 months.
7. Treatment with oral antidiabetic drugs (OAD) (except metformin
which is permitted) at any time from the diagnosis.
8. Treatment with any investigational drug within the last 3 months.
9. Any known medical condition impacting red blood cells production
or destruction such as hemoglobinopathy, polycythemia, splenectomy,
iron deficiency anemia, hemorrhage, myelodysplastic disease or
receipt or donation of blood or plasma products within the last 3
months.
10. Patient or parent/legally authorized representative(s) unable to
understand the nature and scope of the study, unable to read and write
or unlikely to comply with the protocol, e.g. inability and
unwillingness to complete the questionnaires.
11. Children or relatives of the Investigators, research assistants, study
coordinator or other staff directly involved in the conduct of the
protocol, employee of the Sponsor or of Sponsor’s representatives.
