Adherence Intervention to Promote Optimal Use of Insulin Pumps in Adolescents With Type 1 Diabetes (Pump It Up!)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: Adherence behavior that needs improvement is targeted; Behavioral: Adherence behaviors and recommendations for improvement.

Study type: Interventional

Funder types: Other

Identifiers

NCT02333539

15-0965

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• developmental delay

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Tailored feedback

Experimental group

Description:

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.

Treatment:

Behavioral: Adherence behaviors and recommendations for improvement.

Problem Solving

Experimental group

Description:

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.

Treatment:

Behavioral: Adherence behavior that needs improvement is targeted

Treatment as Usual

No Intervention group

Description:

Standard of care as provided by the endocrinologist occurs.