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

University of Colorado, Denver100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Type 1 Diabetes

Interventions

Adherence behaviors and recommendations for improvement.BEHAVIORAL

Adherence behavior that needs improvement is targetedBEHAVIORAL

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ages 10-17 years * type 1 diabetes diagnosis at least 1 year * use insulin pump Exclusion Criteria: * developmental delay

Locations (1)

Florida State University

Tallahassee, Florida, United States

Outcomes

Primary Outcomes

Frequency of Insulin Pump Adherence Behaviors

Frequency of blood glucose monitoring per day; frequency of carbohydrate inputs per day; frequency of insulin boluses per day; frequency of insulin boluses that follow a high (\>150 mg/dL) or very high (\>250mg/dL) blood glucose result.

Time frame: every 3 months up to 12 months

Secondary Outcomes

Change in Glycemic Control (A1C)

Glycemic control (A1C) will be measured with a Siemens Healthcare Diagnostics DCA Vantage, which is National Glycohemoglobin Standardization Program certified as having documented traceability to the Diabetes Control and Complications Trial Reference Method; range 4.2-6.5%.

Time frame: every 3 months up to 12 months

Data from ClinicalTrials.gov

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