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.

Diabetes Mellitus, Type 1 Clinical Trial

— NIDDK T1D  

Official title:

NIDDK Share Plus: Continuous Glucose Monitoring With Data Sharing in Older Adults With T1D and Their Care Partners

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937321
• Other study ID #: 00160673
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: February 2024
• Source: University of Utah
• Contact: Bruno Gonzales, BA
• Phone: 8015855958
• Email: Bruno.Rodriguez-Gonzales[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: February 28, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria for PWD:

• 60 + years of age

• Type 1 Diabetes Diagnosis

• HbA1c greater than or equal to 7.5% and less than or equal to 11%

• 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

• Naive to using Follow app and willing to use the Follow app

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	University of Utah College of Nursing	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diabetes Appraisal	1 item. Minimum score is 1 and maximum score is 3. The lower the score the worse the outcome.	Change 12 weeks to 24 weeks
Other	Supportive and Unsupportive Behaviors	15 items. The minimum score is 15 and the maximum score is 75. A lower score on the Emotional Support, Instrument Support and Collaboration subscales indicate a worse outcome. A higher score on the Unsupportive/controlling scale indicates a worse outcome.	Change 12 weeks to 24 weeks
Other	Quality of Relationships Inventory	24 items. Minimum score is 24 and maximum score is 120. The lower the score the worse the outcome.	Change 12 weeks to 24 weeks
Other	Care Partner Burden	1 item. Minimum score is 1 and maximum score is 5.	Change 12 weeks to 24 weeks
Other	Diabetes Self-Care Inventory Revised	15 Items. Minimum score is 15 and maximum score is 75. The lower the score the worse the outcomes.	Change 12 weeks to 24 weeks
Other	World Health Organisation-Five Well-Being Index	The minimum score is 0 and the maximum score is 100. Lower scores indicate worse well-being.	Change 12 weeks to 24 weeks
Primary	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	Diabetes Distress for Adults with Type 1 Diabetes	28 items. Minimum score is 0 and maximum score is 28. A higher score indicates a worse outcome.	Change 12 weeks to 24 weeks
Secondary	Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes	21 items. Minimum score is 0 and maximum score is 21. A higher score indicates a worse outcome.	Change 12 weeks to 24 weeks