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Clinical Trials/NCT01829555
NCT01829555
Completed
Not Applicable

A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

UConn Health1 site in 1 country10 target enrollmentFebruary 2013
ConditionsType 1 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
UConn Health
Enrollment
10
Locations
1
Primary Endpoint
change from baseline in number of self-monitoring of blood glucose tests conducted
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
August 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
UConn Health
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

change from baseline in number of self-monitoring of blood glucose tests conducted

Time Frame: 6 months

Secondary Outcomes

  • change from baseline in hemoglobin A1c levels(6 months)

Study Sites (1)

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