Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2016-09-01
2019-12-31
Brief Summary
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Detailed Description
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1. To estimate how well a reinforcement intervention increases usage of CGM. The proportion of days on which participants wear the CGM will be determined as well as the number of weeks during which CGM is worn at least 5 days. We will compare usage rates in the pilot trial to historical control data of patients initiating CGM.
2. To evaluate the association between CGM usage and A1c. We expect A1c will decrease over time in patients who receive the reinforcement intervention. Patients who continue using the CGM are expected to have greater decreases in A1c than patients who discontinue its usage.
Evaluations will be conducted at time of CGM initiation, and 6, 13, 19, 26, and 39 weeks after treatment initiation to assess effects of the intervention and estimate effect sizes.
In addition to the primary aims, secondary outcomes will also be evaluated. Continued use of CGM is expected to improve aspects of diabetes management and daily functioning. Predictors of continued CGM usage and improvements in A1c will also be evaluated.
Results from this pilot study will be instrumental for guiding a subsequent, larger and longer term randomized study for evaluating reinforcement interventions for improving uptake of CGM, other diabetes-related adherence behaviors, and long-term outcomes.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Reinforcement for wearing CGM
The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.
Reinforcement for wearing CGM
The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.
Interventions
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Reinforcement for wearing CGM
The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. diagnosis of type 1 diabetes (T1D) \>12 months via ADA guidelines
3. average A1c \>7.5% and \<14% during the year before study entry, and most recent A1c \>7.5% but \<14%;
4. have ordered and received a CGM, but have not used a CGM \>3 days a week on average during the past 6 months.
5. test blood glucose levels at least 2 times per day on average;
6. access to a computer with internet for uploading CGM data;
7. access to a cell phone to communicate with research staff;
8. English speaking, able to read at \>5th grade level, and pass an informed consent quiz; and adequate knowledge of insulin dosing and dietary recommendations for managing T1D.
Exclusion Criteria
2. have a major visual impairment;
3. have a significant other medical condition that impacts diabetes management (e.g., rheumatoid arthritis, or other condition that requires steroid treatment);
4. plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched.
5. Fail to complete the baseline phase wearing the CGM.
13 Years
26 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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William Tamborlane, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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Other Identifiers
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1603017504
Identifier Type: -
Identifier Source: org_study_id
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