Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Optimizing Adherence and Glycemia in Youth With New IDDM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745342
• Other study ID #: 92-23
• Secondary ID: R01DK046887
• Status: Completed
• Phase: N/A
• Start date: March 1999
• Est. completion date: October 2002

Study information

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

Clinical Trial Summary

This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• 8 to 17 years old

• Duration of type 1 diabetes between 2 months and 6 years

• Residence in New England or New York

• At least 1 outpatient visit in the past year

Exclusion Criteria:

• Major co-morbid psychiatric or medical illness in youth

• Diagnosis of an active major psychiatric disorder in either parent

• Diagnosis of a life-threatening medical illness in either parent

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Family Teamwork Intervention
Families in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Anderson BJ, Vangsness L, Connell A, Butler D, Goebel-Fabbri A, Laffel LM. Family conflict, adherence, and glycaemic control in youth with short duration Type 1 diabetes. Diabet Med. 2002 Aug;19(8):635-42. — View Citation

Laffel LM, Connell A, Vangsness L, Goebel-Fabbri A, Mansfield A, Anderson BJ. General quality of life in youth with type 1 diabetes: relationship to patient management and diabetes-specific family conflict. Diabetes Care. 2003 Nov;26(11):3067-73. — View Citation

Laffel LM, Vangsness L, Connell A, Goebel-Fabbri A, Butler D, Anderson BJ. Impact of ambulatory, family-focused teamwork intervention on glycemic control in youth with type 1 diabetes. J Pediatr. 2003 Apr;142(4):409-16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control, assessed by hemoglobin A1c	Change in A1c from baseline to 2 years, measured every 3 months	2 years
Secondary	Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey	Measured at baseline, 1 year, and 2 years	2 years
Secondary	Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions)	Measured at baseline, 1 year, and 2 years	2 years
Secondary	Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions)	Measured at baseline, 1 year, and 2 years	2 years