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

Type 1 Diabetes Clinical Trial

— Pump It Up!  

Official title:

Adherence Intervention to Promote Optimal Use of Insulin Pumps in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333539
• Other study ID #: 15-0965
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: August 20, 2018

Study information

• Verified date: July 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• ages 10-17 years

• type 1 diabetes diagnosis at least 1 year

• use insulin pump

Exclusion Criteria:

• developmental delay

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Adherence behaviors and recommendations for improvement.

• Adherence behavior that needs improvement is targeted

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	every 3 months up to 12 months
Secondary	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%.	every 3 months up to 12 months