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.
NIDDK T1D
NIDDK Share Plus: Continuous Glucose Monitoring With Data Sharing in Older Adults With T1D and Their Care Partners
1 other identifier
interventional
168
1 country
1
Brief Summary
The purpose of this study is to test the Share plus intervention aimed at improving the use of data sharing between people with diabetes and their care partners in order to maximize the benefits of continuous glucose monitoring. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2023
CompletedFirst Posted
Study publicly available on registry
July 10, 2023
CompletedStudy Start
First participant enrolled
November 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
ExpectedApril 13, 2026
April 1, 2026
2.5 years
June 21, 2023
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time in Range
Time in Range equals 70-180 mg/dl, collected from Clarity reports- 14 days at each timepoint; glycemic metrics: collect from Clarity report - 14 days including hypoglycemic range (less than 60 mg/dl), hyperglycemic range (181-249 and greater than 250 mg/dl), and glycemic variability coefficient value; Hemoglobin A1C (A1C): Collected via home A1c test kits, provided and processed by University of Minnesota Advanced Research and Diagnostic Laboratory.
Change from 12 weeks to 24 weeks
Secondary Outcomes (2)
Diabetes Distress for Adults with Type 1 Diabetes
Change 12 weeks to 24 weeks
Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes
Change 12 weeks to 24 weeks
Other Outcomes (6)
Diabetes Appraisal
Change 12 weeks to 24 weeks
Supportive and Unsupportive Behaviors
Change 12 weeks to 24 weeks
Quality of Relationships Inventory
Change 12 weeks to 24 weeks
- +3 more other outcomes
Study Arms (2)
Intervention Group- Virtual with Dyad Follow + Share plus
EXPERIMENTALThe 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.
Control Group- Virtual with Dyad Follow + Diabetes Self-Management Education
ACTIVE COMPARATORParticipants will receive diabetes self-management education using the Association of Diabetes Care and Education Specialists 7 education curriculum (ADCES7).
Interventions
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
Diabetes self-management education materials
Eligibility Criteria
You may qualify if:
- + years of age
- 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
You may not qualify if:
- Life expectancy estimated at \< 1 year
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah College of Nursing
Salt Lake City, Utah, 84112, United States
Related Publications (1)
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.
PMID: 39680874DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy A Allen, PhD
University of Utah College of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 21, 2023
First Posted
July 10, 2023
Study Start
November 2, 2023
Primary Completion
April 20, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share