Completed

A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

contingency management

Behavioral
Who is being recruted

Autoimmune Diseases+5

+ Diabetes Mellitus

+ Endocrine System Diseases

From 15 to 21 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUConn Health
Last updated: November 10, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01829555
Principal SponsorUConn Health
Last updated: November 10, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 15 to 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusEndocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 1

Criteria

6 inclusion criteria required to participate
English speaking and able to read at > 5th grade level

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

age 15-21 years old

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

Show More Criteria

7 exclusion criteria prevent from participating
are participating in another clinical trial

are pregnant or trying to become pregnant

have a major psychiatric or neurocognitive disorder that would inhibit participation

have a major visual impairment

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The intervention will provide escalating financial reinforcement for self-monitored blood glucose testing.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Pediatric Endocrinology, Yale University

New Haven, United StatesOpen Pediatric Endocrinology, Yale University in Google Maps
CompletedOne Study Center