National Institute of Diabetes and Digestive Kidney Diseases* Share Plus: Continuous Glucose Monitoring with Data Sharing in Older Adults with Type 1 Diabetes* and Their Care Partners to Improve Time in Range and Reduce Diabetes Distress.
NCT ID: NCT05937321
Last Updated: 2025-01-31
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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RECRUITING
NA
160 participants
INTERVENTIONAL
2023-11-02
2026-02-28
Brief Summary
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Hypothesis: Compared to the control group, persons with diabetes enrolled in the Share plus intervention group will experience clinically significant improvements in time-in-range (TIR) (\>5%) at 12- and 24-weeks into the study, and improvement on diabetes distress. Care partners enrolled in the Share plus intervention group will experience lower diabetes distress at 12- and 24-weeks into the study.
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Detailed Description
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Our central hypothesis is that Share plus will result in increased time-in-range and decreased diabetes distress for both persons with diabetes (PWD) and their care partners (CPs) compared to the control group. The rationale for this pilot study is that demonstrating the efficacy of Share plus will provide new opportunities for a clinically useful approach to increase time in glucose range and decrease diabetes distress among older adults with T1D and their care partners. The central hypothesis will be tested by pursuing three specific aims: 1) evaluate feasibility, usability, and acceptability of the Share plus intervention compared to the control group receiving data sharing with diabetes self-management education, 2) evaluate the effect of Share plus intervention on time-in-range and Diabetes Distress, and 3) explore the differences between groups in PWD and CP dyadic appraisal and coping, quality of life, diabetes self-care and care partner burden. To test our central hypothesis, we will conduct a pilot randomized 1:1 control trial in older adults with T1D already using CGM (N=80 dyads) in a telehealth format where the intervention group will receive data sharing and Share plus and the control group will receive diabetes self-management education and assistance setting up the data sharing app. The trial will include a 12-week active intervention to determine a change in primary outcomes and a 12-week observation-only phase to determine maintenance of changes. The research proposed in this application is innovative because it provides a needed and substantive departure from the status quo by bringing a dyadic perspective of T1D management using data-sharing technology.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group- Virtual with Dyad Follow + Share plus
The Share plus intervention is a behavioral intervention administered by a certified diabetes education and care specialist (CDCES) using telehealth. Share plus consists of three educational sessions to facilitate dyads' success in data sharing glucose levels. The Share plus intervention has five major components that are delivered using techniques of motivational interviewing: 1) shared appraisal, 2) communication strategies, 3) problem-solving strategies, 4) action planning and, 5) re-evaluating, practicing, and advancing.
Share plus intervention
Participants will receive the Share plus intervention:
* Set up Follow app
* Start Share plus intervention
* Communication and problem-solving strategies
* Detailed action plan including glucose targets
* Review communication and problems
* New communication content
* Revise action plan as needed for communication and problem-solving hypo- and hyperglycemia,
* Dyadic glucose pattern management training using Clarity, set automatic Clarity downloads
* Dyad set goals for regular times to discuss glucose trends and problem-solving
* Dyadic review of glucose targets after an in-depth analysis of CGM data and dyadic treatment strategies to improve glucose TIR
Control Group- Virtual with Dyad Follow + Diabetes Self-Management Education
Participants will receive diabetes self-management education using the Association of Diabetes Care and Education Specialists 7 education curriculum (ADCES7).
Control group
Diabetes self-management education materials
Interventions
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Share plus intervention
Participants will receive the Share plus intervention:
* Set up Follow app
* Start Share plus intervention
* Communication and problem-solving strategies
* Detailed action plan including glucose targets
* Review communication and problems
* New communication content
* Revise action plan as needed for communication and problem-solving hypo- and hyperglycemia,
* Dyadic glucose pattern management training using Clarity, set automatic Clarity downloads
* Dyad set goals for regular times to discuss glucose trends and problem-solving
* Dyadic review of glucose targets after an in-depth analysis of CGM data and dyadic treatment strategies to improve glucose TIR
Control group
Diabetes self-management education materials
Eligibility Criteria
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Inclusion Criteria
* Type 1 Diabetes Diagnosis
* HbA1c no greater than 11.0%
* Currently using continuous glucose monitoring
* Able to manage diabetes with respect to insulin administration and glucose monitoring (which may include assistance from a care partner
* ≥18 years of age
* Participant understands the study protocol and agrees to comply with it
Exclusion Criteria
* Extreme visual or hearing impairment that would hinder the ability to use CGM
* Stage 4 or 5 renal disease or most recent Glomerular filtration rate (GFR) \<30 ml/min/m2 from a local lab within the past six months
* The presence of a significant medical or psychiatric condition or use of a medication that in the investigator's judgment may affect the completion of any aspect of the protocol.
* Clinical diagnosis of moderate or severe dementia
* Inpatient psychiatric treatment in the past six months
* Participation in an intervention study in the past six weeks
* Montreal Cognitive Assessment Score \< 19
* Cognitive impairment or dementia
* Medical condition that will make it inappropriate or unsafe to fulfill the role of a CP
60 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Nancy Ann Allen
Associate Professor
Principal Investigators
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Nancy A Allen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah College of Nursing
Locations
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University of Utah College of Nursing
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Allen NA, Berg CA, Iacob E, Gonzales BR, Butner JE, Litchman ML. Examining Share plus-A Continuous Glucose Monitoring Plus Data-Sharing Intervention in Older Adults and Their Care Partners: Protocol for a Randomized Control Study. JMIR Res Protoc. 2024 Dec 16;13:e60004. doi: 10.2196/60004.
Other Identifiers
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00160673
Identifier Type: -
Identifier Source: org_study_id
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