Diabetes Mellitus, Type 1NIDDK T1DNCT05937321
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.
A study testing Share plus intervention in people with Diabetes Mellitus, Type 1, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Share plus intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- ≥18 years of age
- Participant understands the study protocol and agrees to comply with it
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah College of Nursing
Salt Lake City, Utah, 84112
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Share plus intervention, Control group
- Keywords
- T1D, diabetes, cgm, telehealth, care partner, data sharing, diabetes education, older adult
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Share plus interventionBehavioural
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 groupBehavioural
Diabetes self-management education materials
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group- Virtual with Dyad Follow + Share plus | Experimental | 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. Receives: Behavioral: Share plus intervention |
| Control Group- Virtual with Dyad Follow + Diabetes Self-Management Education | Active comparator | Participants will receive diabetes self-management education using the Association of Diabetes Care and Education Specialists 7 education curriculum (ADCES7). Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from 12 weeks to 24 weeks
Secondary outcomes (2)
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.
Measured: Change 12 weeks to 24 weeks
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.
Measured: Change 12 weeks to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start2 Nov 2023
- Primary completion20 Apr 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Ann Allen, University of Utah
- Investigators
- Nancy A Allen, PhD, Principal investigator, University of Utah College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937321
- Sponsor's protocol ID
- 00160673
- Acronym
- NIDDK T1D
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39680874
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIDDK Share Plus: Continuous Glucose Monitoring With Data Sharing in Older Adults With T1D and Their Care Partners
- ClinicalTrials.gov ID
- NCT05937321
- Acronym / sponsor ID
- NIDDK T1D / 00160673
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- T1D, diabetes, cgm, telehealth, care partner, data sharing, diabetes education, older adult
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group- Virtual with Dyad Follow + Share plus | Experimental | Behavioral: Share plus interventionThe 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 comparator | Behavioral: Control groupParticipants will receive diabetes self-management education using the Association of Diabetes Care and Education Specialists 7 education curriculum (ADCES7). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Share plus interventionParticipants 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 | Behavioural | Intervention Group- Virtual with Dyad Follow + Share plus |
| Control groupDiabetes self-management education materials | Behavioural | Control Group- Virtual with Dyad Follow + Diabetes Self-Management Education |
Primary outcome
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.
2 secondary outcomes
Diabetes Distress for Adults with Type 1 Diabetes
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 39680874Allen 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.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Allen, PhD principal investigator
University of Utah College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Share plus intervention in people with Diabetes Mellitus, Type 1, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (time frame: Change from 12 weeks to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.