Intensive Care Program for Youth With Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Intensive Care Program for Youth With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961974
• Other study ID #: 02-06
• Secondary ID: R01DK046887
• Status: Completed
• Phase: N/A
• Start date: April 2002
• Est. completion date: June 2005

Study information

• Verified date: August 2021
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Care Ambassador Intervention
Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.
• Psychoeducational Intervention
A psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing "diabetes burnout".

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Charles H. Hood Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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/pe — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control, assessed by hemoglobin A1c		Every 3 months
Secondary	Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)		Annually
Secondary	Weight, assessed by z-BMI (age- and gender-adjusted body mass index)		Every 3 months
Secondary	Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia		Every 3 months