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)

June 25, 2026 updated by: Nancy Ann Allen, University of Utah

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Active Comparator: 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).
Behavioral: Control group
Diabetes self-management education materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Range
Time Frame: Change from 12 weeks to 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Distress for Adults with Type 1 Diabetes
Time Frame: Change 12 weeks to 24 weeks
28 items. Minimum score is 0 and maximum score is 28. A higher score indicates a worse outcome.
Change 12 weeks to 24 weeks
Diabetes Distress Scale for Partners of Adults with Type 1 Diabetes
Time Frame: Change 12 weeks to 24 weeks
21 items. Minimum score is 0 and maximum score is 21. A higher score indicates a worse outcome.
Change 12 weeks to 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Appraisal
Time Frame: Change 12 weeks to 24 weeks
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
Supportive and Unsupportive Behaviors
Time Frame: Change 12 weeks to 24 weeks
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
Quality of Relationships Inventory
Time Frame: Change 12 weeks to 24 weeks
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
Care Partner Burden
Time Frame: Change 12 weeks to 24 weeks
1 item. Minimum score is 1 and maximum score is 5.
Change 12 weeks to 24 weeks
Diabetes Self-Care Inventory Revised
Time Frame: Change 12 weeks to 24 weeks
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
World Health Organisation-Five Well-Being Index
Time Frame: Change 12 weeks to 24 weeks
The minimum score is 0 and the maximum score is 100. Lower scores indicate worse well-being.
Change 12 weeks to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Nancy A Allen, PhD, University of Utah College of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Actual)

April 20, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00160673

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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