Clinical trial NCT05937321: 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.
Official title: NIDDK Share Plus: Continuous Glucose Monitoring with Data Sharing in Older Adults with T1D and Their Care Partners
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: T1D
diabetes
cgm
telehealth
care partner
data sharing
diabetes education
older adult
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Older adults with type 1 diabetes (T1D) have an increased risk of hypoglycemia and hyperglycemia that can result in grave health consequences, such as seizures, falls, and myocardial infarctions. Care partners (e.g., spouses, friends) regularly become part of the diabetes care team to assist in self-management as a person with diabetes ages. A technological advancement that is available to people with diabetes and their care partners to address harmful hypoglycemia and hyperglycemia is to use continuous glucose monitoring (CGM), with a data-sharing app that allows the older adult with T1D and their care partner (dyad) to see glucose data on their smart-phones and to receive an alert before hypoglycemia or hyperglycemia occurs. Our long-term goal is to leverage the full potential of technology and care partner interventions to optimize the support that care partners can provide for effective glucose management in older adults with T1D. Our overall objective is to test an intervention, called Share plus, aimed at improving the use of data sharing between persons with diabetes and their care partners in order to maximize the benefits of CGM. The Share plus intervention provides instruction to current CGM users about how to set up the data sharing app, dyadic communication and problem solving, and how to establish a data-sharing action plan for older adults with T1D and their care partners.

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.

Eligibility criteria: Inclusion Criteria for PWD:

* 60 + 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

Inclusion Criteria for CP:

* ≥18 years of age
* Participant understands the study protocol and agrees to comply with it

Exclusion Criteria for PWD:

* 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

Exclusion criteria for CP:

* Cognitive impairment or dementia
* Medical condition that will make it inappropriate or unsafe to fulfill the role of a CP

Primary outcomes:
measure: Time in Range
timeFrame: Change from 12 weeks to 24 weeks
Secondary outcomes:
measure: Diabetes Distress for Adults with Type 1 Diabetes
timeFrame: Change 12 weeks to 24 weeks
measure: Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes
timeFrame: Change 12 weeks to 24 weeks
Other outcomes:
measure: Diabetes Appraisal
timeFrame: Change 12 weeks to 24 weeks
measure: Supportive and Unsupportive Behaviors
timeFrame: Change 12 weeks to 24 weeks
measure: Quality of Relationships Inventory
timeFrame: Change 12 weeks to 24 weeks
measure: Care Partner Burden
timeFrame: Change 12 weeks to 24 weeks
measure: Diabetes Self-Care Inventory Revised
timeFrame: Change 12 weeks to 24 weeks
measure: World Health Organisation-Five Well-Being Index
timeFrame: Change 12 weeks to 24 weeks
Locations:
city: Salt Lake City
country: United States
facility: University of Utah College of Nursing
state: Utah
Study officials:
affiliation: University of Utah College of Nursing
name: Nancy A Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References: