Adherence Intervention to Promote Optimal Use of Insulin Pumps in Adolescents With Type 1 Diabetes

NCT ID: NCT02333539

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2018-08-20

Brief Summary

The overall objective of this study is to address the critical need of improving insulin pump adherence in adolescents with Type 1 Diabetes (T1D) by providing personalized intervention using evidence-based techniques during routine diabetes clinic visits at point of care.

Detailed Description

To achieve optimal use of the insulin pump, patients must engage in frequent Blood Glucose Monitoring (BGM) and insulin bolusing, and have an understanding of their relationship. BGM must occur and then it must be followed by a decision about what to do (or not do) regarding insulin bolusing. If insulin bolusing occurs in the absence of BGM, hypoglycemia and less than ideal glycemic control can occur. Of the few insulin pump adherence studies, only very basic adherence behaviors such as BGM and insulin bolusing frequency or number of hypoglycemic events have been reported.

The overall objective of this study is to address the critical need of improving insulin pump adherence in adolescents with T1D by providing personalized intervention using evidence-based techniques during routine diabetes clinic visits at point of care.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tailored feedback

Participants are provided a Tailored Feedback report based on data downloaded from their insulin pumps. Summaries are provided about insulin pump adherence behaviors and recommendations for improvement are made.

Group Type: EXPERIMENTAL

Adherence behaviors and recommendations for improvement.

Intervention Type: BEHAVIORAL

Problem Solving

Participants receive a problem-solving session based on data downloaded from their insulin pumps. An insulin pump adherence behavior that needs improvement is targeted; goals are set and solutions generated.

Group Type: EXPERIMENTAL

Adherence behavior that needs improvement is targeted

Intervention Type: BEHAVIORAL

Treatment as Usual

Standard of care as provided by the endocrinologist occurs.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adherence behaviors and recommendations for improvement.

Intervention Type: BEHAVIORAL

Adherence behavior that needs improvement is targeted

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ages 10-17 years
• type 1 diabetes diagnosis at least 1 year
• use insulin pump

Exclusion Criteria

• developmental delay

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly A Driscoll, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Florida State University

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

15-0965

Identifier Type: -

Identifier Source: org_study_id