Diabetes Mellitus, Type IINCT03012074
Episodic to Real-Time Care in Diabetes Self-Management
A study testing Type 2 Diabetes Self-Management in people with Diabetes Mellitus, Type II, run by Duke University at 1 site in United States.
Trial summary
This study will use mobile health technologies to provide everyday data to help patients and their care providers better understand illness dynamics and develop adaptive approaches to improve health outcomes in diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- Type 2 Diabetes Self-Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2017to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- able to speak and read English
- diagnosed with type 2 diabetes mellitus
- told by their primary care provider to monitor their blood sugar daily
- owning and using a smart phone
- capable of giving informed consent
- with no pre-existing severe medical condition(s) that would interfere with study participation (e.g., renal failure, severe orthopedic conditions or joint replacement scheduled within 6 months, paralysis, or cancer)
Who cannot join
- active dementia or psychiatric illness
- reside in a nursing home
- participating in another self-management study
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Nursing
Durham, North Carolina, 27710
About this study
Official title: From Episodic to Real-Time Care in Diabetes Self-Management
This study will use mobile health technologies to provide everyday data to help patients and their care providers better understand illness dynamics and develop adaptive approaches to improve health outcomes in diabetes. Specifically, the study will identify strategies to help patients adapt using multiple types of self-generated diabetes-related data and help providers guide patients to better self-manage in real-time, when guidance is needed most.
Read the detailed description
The investigators will conduct a mixed-methods exploratory designed study and recruit 60 adult patients (age ≥ 18) with type 2 diabetes who will track relevant clinical data over 6 months. Participants will be asked to use a wireless glucose monitor, a cellular body scale, and a wrist-worn accelerometer, and respond to short bi-weekly text message-based surveys on medication adherence for 6 months. Data generated from the devices will be plotted as trajectories that will allow us to conduct trajectory analyses and identify missing data points and trends leading to attrition, in order to assess the feasibility of having patients engage in this type of self-monitoring for 6 months. A subset of 20 patients will be interviewed via telephone at the end of their 6 month self-monitoring period to discuss their adaptive challenges and successes over the study period. The investigators will present the trajectories of their data during patient interviews using a visual that we will e-mail or postal mail, depending on patient preference. This will facilitate discussion of the challenges participants face in self-management and adaptive practices participants use. Following the 6 months of self-monitoring, we will conduct interviews with health care providers in which the investigators will present the data trajectories and explore ways to achieve continual communication and address real-time challenges with diabetes self-management.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Type 2 Diabetes Self-Management
- Keywords
- diabetes, mHealth, mobile health technology
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 2 Diabetes Self-ManagementBehavioural
Patients with Type 2 Diabetes
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type II Diabetes | Experimental | Patients with Type II Diabetes Receives: Behavioral: Type 2 Diabetes Self-Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with type II diabetes who adhere to using mobile technologies to self-monitor multiple types of diabetes-related data
Measured: 6 months
Secondary outcomes (6)
Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months.
Measured: 6 months
Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months.
Measured: 6 months
Change in daily blood glucose levels in patients with diabetes over a 6 month period
Data generated from the phone-tethered glucose monitor and plotted as a trajectory over a 6 month period
Measured: 6 months
Change in daily weight in patients with diabetes over a 6 month period
Data generated from the cellular body scale and plotted as a trajectory over a 6 month period
Measured: 6 months
Change in daily physical activity in patients with diabetes over a 6 month period
Data generated from the wrist-worn accelerometer and plotted as a trajectory over a 6 month period
Measured: 6 months
Medication adherence Survey
bi-weekly text message-based surveys on medication adherence over a 6 month period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start2 Mar 2017
- Primary completion1 May 2018
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan J Shaw, PhD, RN, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012074
- Sponsor's protocol ID
- Pro00071569
- Status last verified
- Jan 2020
- First submitted
- 21 Dec 2016
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Episodic to Real-Time Care in Diabetes Self-Management
- ClinicalTrials.gov ID
- NCT03012074
- Acronym / sponsor ID
- Pro00071569
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- diabetes, mHealth, mobile health technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
This study will use mobile health technologies to provide everyday data to help patients and their care providers better understand illness dynamics and develop adaptive approaches to improve health outcomes in diabetes. Specifically, the study will identify strategies to help patients adapt using multiple types of self-generated diabetes-related data and help providers guide patients to better self-manage in real-time, when guidance is needed most.
Detailed description
The investigators will conduct a mixed-methods exploratory designed study and recruit 60 adult patients (age ≥ 18) with type 2 diabetes who will track relevant clinical data over 6 months. Participants will be asked to use a wireless glucose monitor, a cellular body scale, and a wrist-worn accelerometer, and respond to short bi-weekly text message-based surveys on medication adherence for 6 months. Data generated from the devices will be plotted as trajectories that will allow us to conduct trajectory analyses and identify missing data points and trends leading to attrition, in order to assess the feasibility of having patients engage in this type of self-monitoring for 6 months. A subset of 20 patients will be interviewed via telephone at the end of their 6 month self-monitoring period to discuss their adaptive challenges and successes over the study period. The investigators will present the trajectories of their data during patient interviews using a visual that we will e-mail or postal mail, depending on patient preference. This will facilitate discussion of the challenges participants face in self-management and adaptive practices participants use. Following the 6 months of self-monitoring, we will conduct interviews with health care providers in which the investigators will present the data trajectories and explore ways to achieve continual communication and address real-time challenges with diabetes self-management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Type II Diabetes | Experimental | Behavioral: Type 2 Diabetes Self-ManagementPatients with Type II Diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years old
- able to speak and read English
- diagnosed with type 2 diabetes mellitus
- told by their primary care provider to monitor their blood sugar daily
- owning and using a smart phone
Key exclusion criteria (3 listed)
- active dementia or psychiatric illness
- reside in a nursing home
- participating in another self-management study
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 |
|---|---|---|
| Type 2 Diabetes Self-ManagementPatients with Type 2 Diabetes | Behavioural | Patients with Type II Diabetes |
Primary outcome
Number of participants with type II diabetes who adhere to using mobile technologies to self-monitor multiple types of diabetes-related data
Time frame: 6 months
6 secondary outcomes
Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months.
Time frame: 6 months
Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months.
Time frame: 6 months
Change in daily blood glucose levels in patients with diabetes over a 6 month period
Time frame: 6 months
Change in daily weight in patients with diabetes over a 6 month period
Time frame: 6 months
Change in daily physical activity in patients with diabetes over a 6 month period
Time frame: 6 months
Medication adherence Survey
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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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, PhD, RN principal investigator
Duke University School 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 Type 2 Diabetes Self-Management in people with Diabetes Mellitus, Type II, 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 7 inclusion and 3 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 2 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with type II diabetes who adhere to using mobile technologies to self-monitor multiple types of diabetes-related data (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2020.