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

NCT02333539 | Completed DMC

• 1 other identifier: 15-0965
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Glycemic Control (A1C)

  every 3 months up to 12 months

Study Arms (3)

Tailored feedback

EXPERIMENTAL

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.

Behavioral: Adherence behaviors and recommendations for improvement.

Problem Solving

EXPERIMENTAL

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.

Behavioral: Adherence behavior that needs improvement is targeted

Treatment as Usual

NO INTERVENTION

Standard of care as provided by the endocrinologist occurs.

Interventions

Adherence behaviors and recommendations for improvement. BEHAVIORAL

Tailored feedback

Adherence behavior that needs improvement is targeted BEHAVIORAL

Problem Solving

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• developmental delay

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kimberly A Driscoll, Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 7, 2015
• Study Start: September 1, 2012
• Primary Completion: August 20, 2018
• Study Completion: August 20, 2018
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

US (1)