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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Adherence behavior that needs improvement is targeted; Behavioral: Adherence behaviors and recommendations for improvement.

• Registration Number: NCT02333539
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-07
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• developmental delay

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Problem Solving	Adherence behavior that needs improvement is targeted	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.
Tailored feedback	Adherence behaviors and recommendations for improvement.	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.

Primary Outcome Measures

Name	Time	Method
Frequency of Insulin Pump Adherence Behaviors	every 3 months up to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Glycemic Control (A1C)	every 3 months up to 12 months	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%.

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States