An interventional study of Reinforcement for BG testing and Standard of care in Type 1 Diabetes, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
The purpose of this project is to evaluate the efficacy of a behavioral economic intervention to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D. The intervention will reinforce patients for conducting SMBG, with escalating reinforcers provided when patients achieved sustained periods of testing at least 4 times/day at appropriate intervals. A 6-month trial will be conducted in which 60 patients will be randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 62 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
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Exclusion Criteria:
Subjects will receive reinforcement for BG testing. The intervention will reinforce subjects for conducting Self Monitoring of Blood Glucose (SMBG), with escalating reinforcers provided when subjects achieved sustained periods of testing at least 4 times/day at appropriate intervals.
Behavioral: Reinforcement for BG testing · Other: Standard of care
Subjects will receive standard of care without reinforcement for Self Monitoring Blood Glucose
Other: Standard of care
Subjects will receive reinforcement for BG tests. The intervention will reinforce subjects for conducting Self Monitoring of Blood Glucose (SMBG), with escalating reinforcers provided when subjects achieved sustained periods of testing at least 4 times/day at appropriate intervals.
Subjects receive standard of care
To determine if the reinforcement intervention increases SMBG testing.
The number of SMBG tests will be assessed via glucometer uploads, and the proportion of days on which at least 4 tests occurred as well as the longest number of consecutive days on which SMBG tests occurred at frequencies of \>4 times/day will be calculated. The hypothesis is that patients assigned to the reinforcement intervention will conduct more SMBG tests, have greater proportions of days with \>4 tests, and have longer durations of appropriate testing frequencies than patients assigned to usual care.
Time frame: 6 Months
To assess if the intervention reduces A1c
Patients randomized to the reinforcement intervention are expected to have greater decreases in A1c over time than patients assigned to usual care.
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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