Diabetes Mellitus, Type 2EXTENDNCT05120544
Expanding Technology-Enabled Nurse Delivered Chronic Disease Care
A study testing EXTEND Plus and EXTEND in people with Diabetes Mellitus, Type 2 and Hypertension, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether the self-management of diabetes and hypertension can be improved with the use of mobile monitoring devices and nursing support. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- EXTEND Plus and EXTEND
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 13 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes by International Classification of Diseases (ICD) code or treatment with glucose-lowering medication or mention in clinical notes
- Poor diabetes control as indicated by at least 1 HbA1c greater than or equal to 8.0% with NO HbA1c less than 8.0% over the past 6 months
- At least 1 appointment (office visit, appointment, initial consult, telemedicine) at primary clinic site over the past year
- hypertension by ICD code or treatment with blood pressure-lowering medication or mention in clinical notes
- poor hypertension control as indicated by a clinic systolic BP >140 AND/OR diastolic BP >90 over past year
- use of an Apple iPhone or Android smartphone
Show all 9Show fewer
- can provide informed consent
- can read/speak English
- can provide informed consent
Who cannot join
- dementia, psychosis, or life-limiting illness
- acute coronary event in past year
- hypoglycemic seizure/coma over the past year
- residence in a nursing home
- use of an insulin pump
- are or plan to become pregnant
- unable or unwilling to use necessary technology to participate in study
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
The purpose of this study is to investigate whether the self-management of diabetes and hypertension can be improved with the use of mobile monitoring devices and nursing support.
Read the detailed description
EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) seeks to address evidence gaps that prevent practical use of mobile monitoring-enabled telehealth for clinic-refractory chronic diseases, with an initial focus on Persistent Poorly Controlled Diabetes Mellitus (PPDM) and hypertension. Because our population has already proven refractory to usual care, we will conduct an active comparator randomized trial (N=220) of two 12-month interventions: 1) mobile monitoring as a self-management tool (EXTEND); and 2) a nurse-delivered intervention incorporating mobile monitoring, self-management support, and medication management (EXTEND Plus). The medication management is a care team approach where the nurse works with a Pharmacist who has prescribing rights to optimize medications for the patients. This proposal will also allow us to examine a novel application for mobile monitoring technologies, as tools for predicting patient safety events.
Aim 1: Compare the effectiveness of the two 12-month EXTEND interventions for PPDM and hypertension. Hypothesis 1a: Compared to EXTEND, EXTEND Plus will improve primary (HbA1c) and secondary outcomes (e.g., blood pressure, weight, self-management measures) at 12 months; Hypothesis 1b: The relative effects of each intervention will be sustained at 24 months; Hypothesis 1c: Subgroup analyses will identify characteristics associated with high responsiveness to each intervention.
Aim 2: Guide scaling and dissemination of the EXTEND interventions by: (A) interviewing patients and stakeholders to clarify implementation barriers, facilitators and process requirements; (B) comparing intervention costs against potential reimbursement mechanisms; and (C) understanding the role of climate change and other social drivers of health on diabetes self-management and intervention engagement.
Aim 3: Explore the value of combining mobile monitoring and EHR data for predicting patient safety events (hospitalizations, emergency visits) in the EXTEND study cohort over 24 months. Participants will monitor their data using a suite of remote monitoring devices. Data will be analyzed with PACE by our team. If participants are randomized to the telehealth arm, these data will be reviewed by a RN during a telehealth visit to aid in clinical decision making.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- EXTEND Plus, EXTEND
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXTEND PlusBehavioural
The EXTEND Plus approach builds patient self-management capacity by focusing on knowledge, self-efficacy, and goal setting (using an RN-delivered, module-based approach). All material is at an 8th grade reading level. Module topics include, but are not limited to, use of self-monitoring of blood glucose (SMBG), BP monitoring, developing a diet plan, medication adherence, hypoglycemia and hypotension self-management, and self-managing insulin. In addition, this intervention component addresses diet and activity self-management during each encounter.
EXTENDBehavioural
EXTEND patients self-manage using data they collect during the study, and continue to receive standard behavioral counseling from primary providers.
| Study group | Role | What they receive |
|---|---|---|
| EXTEND | Active comparator | EXTEND participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS). Participants can review data and trends within the device apps and modify self-management practices accordingly. The EXTEND group continues chronic disease care with their existing providers during the study, and are instructed at baseline to address management questions via their primary clinics' established avenues (as would be the case for any patient using mobile monitoring in clinical practice). Receives: Behavioral: EXTEND |
| EXTEND Plus | Experimental | EXTEND Plus participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS) for use as part of nurse-delivered intervention combining mobile monitoring, self-management support, and medication management. The intervention is administered by clinical registered nurses (RNs) from Duke Primary Care (DPC) or Duke Endocrinology. For the medication management component, RNs work with a study PharmD affiliated with the participant's clinic. The PharmD determines if medication changes are needed, and prescribes accordingly. The RNs deliver EXTEND Plus via scheduled telephone encounters throughout the 12-month intervention. The initial encounter frequency is every two weeks, but may be extended to every four weeks for patients achieving treatment goals. Receives: Behavioral: EXTEND Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in blood sugar (glucose) attached to hemoglobin. Validated point-of-care or lab-based test.
Measured: Baseline, 3, 6, 9, 12, 18 and 24 months
Secondary outcomes (8)
Change in Systolic Blood Pressure
Measure taken at clinic with standard arm cuff. Measurement is the average of two readings, on the same arm, taken 10 minutes apart.
Measured: Baseline, 3, 6, 9, 12, 18 and 24 months
Change in Diastolic Blood Pressure
Measure taken at clinic with standard arm cuff. Measurement is the average of two readings, on the same arm, taken 10 minutes apart.
Measured: Baseline, 3, 6, 9, 12, 18 and 24 months
Change in Weight
Measurement taken with lab scale, when patient is lightly clothed, shoes off.
Measured: Baseline, 3, 6, 9, 12, 18 and 24 months
Change is Diabetes Distress Scale
Measure of diabetes distress and burden using the Diabetes Distress Scale (DDS): 17 items, Scale 1-6. Scoring: Average. Higher score indicates higher distress level.
Measured: Baseline, 6, 12, 18 and 24 months
Change in Diabetes Self-Management Questionnaire
Measure of diabetes self-care. Diabetes Self-Management Questionnaire (DSMQ): 16 items, Scale 0-3. Scoring: Sum and transform to fall between 0-10. Higher score indicates more effective self-care.
Measured: Baseline, 6, 12, 18 and 24 months
Change in Perceived Competence Scale
Measure of diabetes self-efficacy and capacity. Perceived Competence Scale (PCS): 4 items, Scale 1-7. Scoring: average (1-7) Higher score indicates greater self-efficacy.
Measured: Baseline, 6, 12, 18 and 24 months
Change in Medication Non-adherence
Validated self-report measure using Voils' medication non-adherence measure.
Voils
- Full name: Voils Medication Nonadherence Measure
- Construct: assesses how often a patient misses their prescribed medication and why
- Scale range: 1-5 (the scale consists of 6 likert scale items ranging from 1=None of the time to 5=Every time. The total score is obtained by taking the mean of the items)
- Higher scores indicate greater medication non-adherence.
- There are no subscales.
Measured: Baseline, 6, 12, 18 and 24 months
Change in Diabetes Knowledge
Diabetes Knowledge Questionnaire (DKQ) is a 24-item validated measure.
Diabetes Knowledge
- Full name: Diabetes Knowledge Questionnaire
- Construct: assesses diabetes knowledge
- Scale range: 0-24 (the scale consists of 24 yes-no items that assess diabetes knowledge. One point is given for each item answered correctly.)
- Greater scores indicate greater knowledge of diabetes
- There are no subscales.
Measured: Baseline, 6, 12, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start21 Apr 2022
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Ryan J Shaw, RN, PhD, Principal investigator, Duke University School of NursingMatthew Crowley, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120544
- Sponsor's protocol ID
- PRO00107722
- Other IDs
- 1R01NR019594-01
- Acronym
- EXTEND
- Status last verified
- Oct 2025
- First submitted
- 3 Nov 2021
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our data will be made available for use by investigators not associated with the proposed study within 3 years after the primary results have been published. We will prepare a clear and searchable documentation of the database including a data dictionary, and its linkage to the pertinent study protocols and forms so that diverse investigators can make effective use of the data. For investigators interested in prospective collaborations, we will explore other options to provide support.
Publications
Crowley MJ, Lewinski AA, Yang Q, Hatch D, Palipana A, Bosworth HB, Kaufman BG, Chatterjee R, Pennington G, Matters D, Lee D, Urlichich D, Miller HN, German J, Sang S, Smith B, Kokosa S, Gregory P, Roberson CL, Canupp H, Shaw RJ. Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care : A Pragmatic, Randomized, Effectiveness-Implementation Trial. Ann Intern Med. 2026 Jul;179(7):968-979. doi: 10.7326/ANNALS-26-00132. Epub 2026 Jun 23.
PubMed 42330500Teo KM, Shaw RJ, Alexopoulos AS, Pennington G, Hatch D, Yang Q, Crowley MJ. Comparing the Effects of Diabetes-Specific and Overall Medication Regimen Complexity on Diabetes Distress. Sci Diabetes Self Manag Care. 2026 Apr;52(2):162-173. doi: 10.1177/26350106261422676. Epub 2026 Feb 25.
PubMed 41738686Lee D, Yang Q, Crowley MJ, Hatch D, Pennington G, Matters D, Shaw RJ. Chronic Illness Self-Management Latent Profiles in Individuals With Comorbid Type 2 Diabetes and Hypertension. Sci Diabetes Self Manag Care. 2025 Jun;51(3):250-261. doi: 10.1177/26350106251336311. Epub 2025 May 14.
PubMed 40370006
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Technology-Enabled Nurse Delivered Chronic Disease Care
- ClinicalTrials.gov ID
- NCT05120544
- Acronym / sponsor ID
- EXTEND / PRO00107722
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Posted 1 Oct 2026
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 investigate whether the self-management of diabetes and hypertension can be improved with the use of mobile monitoring devices and nursing support.
Detailed description
EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) seeks to address evidence gaps that prevent practical use of mobile monitoring-enabled telehealth for clinic-refractory chronic diseases, with an initial focus on Persistent Poorly Controlled Diabetes Mellitus (PPDM) and hypertension. Because our population has already proven refractory to usual care, we will conduct an active comparator randomized trial (N=220) of two 12-month interventions: 1) mobile monitoring as a self-management tool (EXTEND); and 2) a nurse-delivered intervention incorporating mobile monitoring, self-management support, and medication management (EXTEND Plus). The medication management is a care team approach where the nurse works with a Pharmacist who has prescribing rights to optimize medications for the patients. This proposal will also allow us to examine a novel application for mobile monitoring technologies, as tools for predicting patient safety events.
Aim 1: Compare the effectiveness of the two 12-month EXTEND interventions for PPDM and hypertension. Hypothesis 1a: Compared to EXTEND, EXTEND Plus will improve primary (HbA1c) and secondary outcomes (e.g., blood pressure, weight, self-management measures) at 12 months; Hypothesis 1b: The relative effects of each intervention will be sustained at 24 months; Hypothesis 1c: Subgroup analyses will identify characteristics associated with high responsiveness to each intervention.
Aim 2: Guide scaling and dissemination of the EXTEND interventions by: (A) interviewing patients and stakeholders to clarify implementation barriers, facilitators and process requirements; (B) comparing intervention costs against potential reimbursement mechanisms; and (C) understanding the role of climate change and other social drivers of health on diabetes self-management and intervention engagement.
Aim 3: Explore the value of combining mobile monitoring and EHR data for predicting patient safety events (hospitalizations, emergency visits) in the EXTEND study cohort over 24 months. Participants will monitor their data using a suite of remote monitoring devices. Data will be analyzed with PACE by our team. If participants are randomized to the telehealth arm, these data will be reviewed by a RN during a telehealth visit to aid in clinical decision making.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXTEND | Active comparator | Behavioral: EXTENDEXTEND participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS). Participants can review data and trends within the device apps and modify self-management practices accordingly. The EXTEND group continues chronic disease care with their existing providers during the study, and are instructed at baseline to address management questions via their primary clinics' established avenues (as would be the case for any patient using mobile monitoring in clinical practice). |
| EXTEND Plus | Experimental | Behavioral: EXTEND PlusEXTEND Plus participants receive 4 mobile monitoring devices to facilitate chronic disease self-management (glucometer, BP cuff, scale, accelerometer). Device data are transferred to Duke University Health System (DUHS) for use as part of nurse-delivered intervention combining mobile monitoring, self-management support, and medication management. The intervention is administered by clinical registered nurses (RNs) from Duke Primary Care (DPC) or Duke Endocrinology. For the medication management component, RNs work with a study PharmD affiliated with the participant's clinic. The PharmD determines if medication changes are needed, and prescribes accordingly. The RNs deliver EXTEND Plus via scheduled telephone encounters throughout the 12-month intervention. The initial encounter frequency is every two weeks, but may be extended to every four weeks for patients achieving treatment goals. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- type 2 diabetes by International Classification of Diseases (ICD) code or treatment with glucose-lowering medication or mention in clinical notes
- Poor diabetes control as indicated by at least 1 HbA1c greater than or equal to 8.0% with NO HbA1c less than 8.0% over the past 6 months
- At least 1 appointment (office visit, appointment, initial consult, telemedicine) at primary clinic site over the past year
- hypertension by ICD code or treatment with blood pressure-lowering medication or mention in clinical notes
- poor hypertension control as indicated by a clinic systolic BP >140 AND/OR diastolic BP >90 over past year
Key exclusion criteria (7 listed)
- dementia, psychosis, or life-limiting illness
- acute coronary event in past year
- hypoglycemic seizure/coma over the past year
- residence in a nursing home
- use of an insulin pump
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 |
|---|---|---|
| EXTEND PlusThe EXTEND Plus approach builds patient self-management capacity by focusing on knowledge, self-efficacy, and goal setting (using an RN-delivered, module-based approach). All material is at an 8th grade reading level. Module topics include, but are not limited to, use of self-monitoring of blood glucose (SMBG), BP monitoring, developing a diet plan, medication adherence, hypoglycemia and hypotension self-management, and self-managing insulin. In addition, this intervention component addresses diet and activity self-management during each encounter. | Behavioural | EXTEND Plus |
| EXTENDEXTEND patients self-manage using data they collect during the study, and continue to receive standard behavioral counseling from primary providers. | Behavioural | EXTEND |
Primary outcome
Change in HbA1c
Time frame: Baseline, 3, 6, 9, 12, 18 and 24 months
Change in blood sugar (glucose) attached to hemoglobin. Validated point-of-care or lab-based test.
8 secondary outcomes
Change in Systolic Blood Pressure
Time frame: Baseline, 3, 6, 9, 12, 18 and 24 months
Change in Diastolic Blood Pressure
Time frame: Baseline, 3, 6, 9, 12, 18 and 24 months
Change in Weight
Time frame: Baseline, 3, 6, 9, 12, 18 and 24 months
Change is Diabetes Distress Scale
Time frame: Baseline, 6, 12, 18 and 24 months
Change in Diabetes Self-Management Questionnaire
Time frame: Baseline, 6, 12, 18 and 24 months
Change in Perceived Competence Scale
Time frame: Baseline, 6, 12, 18 and 24 months
Change in Medication Non-adherence
Time frame: Baseline, 6, 12, 18 and 24 months
Change in Diabetes Knowledge
Time frame: Baseline, 6, 12, 18 and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42330500Crowley MJ, Lewinski AA, Yang Q, Hatch D, Palipana A, Bosworth HB, Kaufman BG, Chatterjee R, Pennington G, Matters D, Lee D, Urlichich D, Miller HN, German J, Sang S, Smith B, Kokosa S, Gregory P, Roberson CL, Canupp H, Shaw RJ. Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care : A Pragmatic, Randomized, Effectiveness-Implementation Trial. Ann Intern Med. 2026 Jul;179(7):968-979. doi: 10.7326/ANNALS-26-00132. Epub 2026 Jun 23.
- Derived from this study: PubMed 41738686Teo KM, Shaw RJ, Alexopoulos AS, Pennington G, Hatch D, Yang Q, Crowley MJ. Comparing the Effects of Diabetes-Specific and Overall Medication Regimen Complexity on Diabetes Distress. Sci Diabetes Self Manag Care. 2026 Apr;52(2):162-173. doi: 10.1177/26350106261422676. Epub 2026 Feb 25.
- Derived from this study: PubMed 40370006Lee D, Yang Q, Crowley MJ, Hatch D, Pennington G, Matters D, Shaw RJ. Chronic Illness Self-Management Latent Profiles in Individuals With Comorbid Type 2 Diabetes and Hypertension. Sci Diabetes Self Manag Care. 2025 Jun;51(3):250-261. doi: 10.1177/26350106251336311. Epub 2025 May 14.
- Individual participant dataSharing planned: Yes. Our data will be made available for use by investigators not associated with the proposed study within 3 years after the primary results have been published. We will prepare a clear and searchable documentation of the database including a data dictionary, and its linkage to the pertinent study protocols and forms so that diverse investigators can make effective use of the data. For investigators interested in prospective collaborations, we will explore other options to provide support.
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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.
Ryan J Shaw, RN, PhD principal investigator
Duke University School of Nursing
Matthew Crowley, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXTEND Plus and EXTEND in people with Diabetes Mellitus, Type 2 and Hypertension, run by Duke University 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 1 Oct 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?
Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in HbA1c (time frame: Baseline, 3, 6, 9, 12, 18 and 24 months). 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 NCT05120544, which also lists 3 linked publications.
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 1 Oct 2026.