Clinical trial NCT00961974: Intensive Care Program for Youth With Diabetes
Official title: Intensive Care Program for Youth With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
hemoglobin A1c
family
involvement
responsibility
conflict
quality of life
children
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Charles H. Hood Foundation
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-08-19
Enrollment: 154
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Age 8-16 years
* Type 1 diabetes diagnosed by standard American Diabetes Association criteria
* Type 1 diabetes duration of at least 6 months
* Residence in northeastern U.S.
* Established clinic patient
* Fluency in English or Spanish

Exclusion Criteria:

* Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation)
* Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)

Primary outcomes:
measure: Glycemic control, assessed by hemoglobin A1c
timeFrame: Every 3 months
Secondary outcomes:
measure: Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)
timeFrame: Annually
measure: Weight, assessed by z-BMI (age- and gender-adjusted body mass index)
timeFrame: Every 3 months
measure: Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia
timeFrame: Every 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Lori Laffel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butler DA, Zuehlke JB, Tovar A, Volkening LK, Anderson BJ, Laffel LM. The impact of modifiable family factors on glycemic control among youth with type 1 diabetes. Pediatr Diabetes. 2008 Aug;9(4 Pt 2):373-81. doi: 10.1111/j.1399-5448.2008.00370.x.
citation: Svoren BM, Volkening LK, Butler DA, Moreland EC, Anderson BJ, Laffel LM. Temporal trends in the treatment of pediatric type 1 diabetes and impact on acute outcomes. J Pediatr. 2007 Mar;150(3):279-85. doi: 10.1016/j.jpeds.2006.12.009.
citation: Moreland EC, Tovar A, Zuehlke JB, Butler DA, Milaszewski K, Laffel LM. The impact of physiological, therapeutic and psychosocial variables on glycemic control in youth with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2004 Nov;17(11):1533-44. doi: 10.1515/jpem.2004.17.11.1533.
citation: Katz ML, Volkening LK, Butler DA, Anderson BJ, Laffel LM. Family-based psychoeducation and Care Ambassador intervention to improve glycemic control in youth with type 1 diabetes: a randomized trial. Pediatr Diabetes. 2014 Mar;15(2):142-50. doi: 10.1111/pedi.12065. Epub 2013 Aug 5.