A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

Type 1 Diabetes Clinical Trial

Official title:

A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829555
• Other study ID #: 13-043-2
• Secondary ID: 1DP3DK097705
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: November 6, 2014
• Start date: February 2013
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Glucose control is necessary to avoid the immediate and long-term adverse effects associated with type 1 diabetes, and frequent self-monitoring of blood glucose is the first important step to achieving glucose control. Data suggest that large proportions of adolescents and young adults fail to adhere to standard guidelines of self-monitored of blood glucose testing and have hemoglobin A1c levels >7.5%. A finite period of poor metabolic control can lead to increased risk of medical complications over an individual's lifespan, necessitating novel interventions to improve self-monitored blood glucose testing and metabolic control in emerging adults with type 1 diabetes. The investigators treatment approach, which provides direct tangible reinforcement for objective evidence of behavior change, is efficacious in decreasing substance use, reducing weight, and improving medication adherence.

The purpose of this project is to develop and pilot test an intervention based on behavioral economic principles for improving self-monitored blood glucose testing in young persons with type 1 diabetes. In this pilot study, patients will text in, via cell phones, each time they test, and a return text will inform them of reinforcer vouchers earned. The investigators will collect data on self-monitored blood glucose testing frequency and A1c levels preceding treatment initiation and throughout a 6 month treatment period. If promising, a randomized trial will lead to larger scale evaluations of reinforcement interventions alone, or in combination with multimodal treatment approaches, and it may be applied to other clinical issues such as adherence to continuous glucose monitoring. Importantly, this intervention can be administered remotely and in an automated fashion, allowing for widespread adoption if efficacious.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 21 Years

Eligibility

Inclusion Criteria:

• age 15-21 years old

• diagnosis of type 1 diabetes (T1D) >12 months via ADA guidelines (Silverstein et al., 2005)

• average A1c >7.5% and <11% during the year before study entry, and most recent A1c >7.5% but <11%

• SMBG user with clinical recommendations to test >4 times/day

• past month SMBG <4 times/ day on average

• English speaking and able to read at >5th grade level

Exclusion Criteria:

• have a major psychiatric or neurocognitive disorder that would inhibit participation

• have a major visual impairment

• meet DSM-IV criteria for pathological gambling

• have a significant other medical condition that impacts diabetes management

• plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched

• are pregnant or trying to become pregnant

• are participating in another clinical trial

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Behavioral:
• contingency management
Participants will receive a voucher for each self-monitored blood glucose test completed during the target testing window, and a bonus amount for each day that 4 tests fall within the testing windows and are separated by more than 2 hours.

Locations

Country	Name	City	State
United States	Pediatric Endocrinology, Yale University	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut Health Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in number of self-monitoring of blood glucose tests conducted		6 months	No
Secondary	change from baseline in hemoglobin A1c levels		6 months	No