Clinical trial NCT01829555: A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management
Official title: A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Yale University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-04-11
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: change from baseline in number of self-monitoring of blood glucose tests conducted
timeFrame: 6 months
Secondary outcomes:
measure: change from baseline in hemoglobin A1c levels
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pediatric Endocrinology, Yale University
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy M Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: William Tamborlane, M.D.
role: PRINCIPAL_INVESTIGATOR
References: