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

Joslin Diabetes Center

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: Family Teamwork Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00745342

R01DK046887 (U.S. NIH Grant/Contract)

92-23

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Teamwork Group

Experimental group

Description:

Families randomized to the Teamwork Group received the behavioral family teamwork intervention.

Treatment:

Behavioral: Family Teamwork Intervention

Standard Care

No Intervention group

Description:

Families in the Standard Care group received standard diabetes care and equal attention from study staff between visits to schedule appointments and encourage regular diabetes follow-up care.