Type 2 Diabetes MellitusNCT02194608
Telemonitoring System Study in Participants With Type 2 Diabetes Mellitus (MK-0000-347)
A study testing Home telehealth system in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
The primary goal is to evaluate whether a home telehealth system that enables the participant to monitor their body weight, blood glucose values and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Home telehealth system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Jul 2013
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- has type 2 diabetes
- treated with oral agents in monotherapy or combined therapy ± basal insulin
- previously educated to self-monitoring blood glucose (SMBG) use
Who cannot join
- has type 2 diabetes non-pharmacologically treated
- has type 2 diabetes treated with multiple daily injections of insulin
- is unable to use the telemedicine system
- pregnancy
- has major cardiovascular, cerebrovascular, or peripheral vascular event in the last 6 months
- has any disease or condition, including alcohol or drugs abuse, that may interfere with study completion
About this study
Official title: A Randomized Clinical Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Individuals With Type 2 Diabetes
The primary goal is to evaluate whether a home telehealth system that enables the participant to monitor their body weight, blood glucose values and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk in individuals with type 2 diabetes mellitus (T2DM), as compared to usual practice.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Home telehealth system
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home telehealth systemDevice
Participants will receive a weighing machine, glucometer, and a sphygmomanometer connected through a Bluetooth system from their home to the Telehealth center via a HUB.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine system | Experimental | Participants will self-test blood glucose level, weight, and blood pressure and results will be uploaded and transmitted directly via a hometelehealth system to a central location (HUB). Blood draws will be administered at baseline and follow-up visits. Receives: Device: Home telehealth system |
| Usual care | No intervention | Participants will self-record their blood glucose levels, blood pressure and weight in a diary. Blood draws will be administered at baseline and follow-up visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood glucose level
Measured: Baseline and 12 months
Change from baseline in blood pressure
Measured: Baseline and 12 months
Change from baseline in body mass index
Measured: Baseline and 12 months
Secondary outcomes (20)
Percentage of participants who achieved hemoglobin A1c (HbA1c) <7.0%
Measured: Up to 12 months
Percentage of participants who achieved blood pressure <130/80 mmHg
Measured: Up to 12 months
Percentage of participants who achieved low-density lipoprotein (LDL) cholesterol <100 mg/dL
Measured: Up to 12 months
Percentage of participants requiring therapy modifications
Measured: Up to 12 months
Change from baseline in total cholesterol
Measured: Baseline, 6 months, and 12 months
Change from baseline in high-density lipoprotein (HDL) cholesterol
Measured: Baseline, 6 months, and 12 months
Change from baseline in LDL cholesterol
Measured: Baseline, 6 months, and 12 months
Change from baseline in triglycerides
Measured: Baseline, 6 months, and 12 months
Change from baseline in cardiovascular risk score
Measured: Baseline, 6 months, and 12 months
Number of emergency room visits and hospital admissions
Measured: Up to 12 months
Number of office visits and home visits
Measured: Up to 12 months
Change from baseline in the number and doses of drugs for treatment of diabetes
Measured: Baseline and 12 months
Change from baseline in the number and doses of drugs for treatment of hypertension
Measured: Baseline and 12 months
Change from baseline in the number and doses of drugs for treatment of dyslipidemia
Measured: Baseline and 12 months
Participant overall satisfaction level
Measured: Up to 12 months
Participant compliance with protocol-provided devices
Measured: Up to 12 months
Number of participants who experienced hypoglycemia
Measured: Up to 12 months
Number of hypoglycemic episodes
Measured: Up to 12 months
Number of participants who experienced severe/symptomatic hypoglycemia
Measured: Up to 12 months
Number of severe/symptomatic hypoglycemic episodes
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startDec 2011
- Primary completionJul 2013
- Study completionJul 2013
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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194608
- Sponsor's protocol ID
- 0000-347
- Other IDs
- LCE#40378
- Status last verified
- Jun 2015
- First submitted
- 16 Jul 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nicolucci A, Cercone S, Chiriatti A, Muscas F, Gensini G. A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes. Diabetes Technol Ther. 2015 Aug;17(8):563-70. doi: 10.1089/dia.2014.0355. Epub 2015 Jul 8.
PubMed 26154338
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02194608
- Acronym / sponsor ID
- 0000-347
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 Jul 2014 (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.
The primary goal is to evaluate whether a home telehealth system that enables the participant to monitor their body weight, blood glucose values and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk in individuals with type 2 diabetes mellitus (T2DM), as compared to usual practice.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine system | Experimental | Device: Home telehealth systemParticipants will self-test blood glucose level, weight, and blood pressure and results will be uploaded and transmitted directly via a hometelehealth system to a central location (HUB). Blood draws will be administered at baseline and follow-up visits. |
| Usual care | No intervention | –Participants will self-record their blood glucose levels, blood pressure and weight in a diary. Blood draws will be administered at baseline and follow-up visits. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- has type 2 diabetes
- treated with oral agents in monotherapy or combined therapy ± basal insulin
- previously educated to self-monitoring blood glucose (SMBG) use
Key exclusion criteria (6 listed)
- has type 2 diabetes non-pharmacologically treated
- has type 2 diabetes treated with multiple daily injections of insulin
- is unable to use the telemedicine system
- pregnancy
- has major cardiovascular, cerebrovascular, or peripheral vascular event in the last 6 months
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 |
|---|---|---|
| Home telehealth systemParticipants will receive a weighing machine, glucometer, and a sphygmomanometer connected through a Bluetooth system from their home to the Telehealth center via a HUB. | Device | Telemedicine system |
Primary outcome
Change from baseline in blood glucose level
Time frame: Baseline and 12 months
Change from baseline in blood pressure
Time frame: Baseline and 12 months
Change from baseline in body mass index
Time frame: Baseline and 12 months
20 secondary outcomes
Percentage of participants who achieved hemoglobin A1c (HbA1c) <7.0%
Time frame: Up to 12 months
Percentage of participants who achieved blood pressure <130/80 mmHg
Time frame: Up to 12 months
Percentage of participants who achieved low-density lipoprotein (LDL) cholesterol <100 mg/dL
Time frame: Up to 12 months
Percentage of participants requiring therapy modifications
Time frame: Up to 12 months
Change from baseline in total cholesterol
Time frame: Baseline, 6 months, and 12 months
Change from baseline in high-density lipoprotein (HDL) cholesterol
Time frame: Baseline, 6 months, and 12 months
Change from baseline in LDL cholesterol
Time frame: Baseline, 6 months, and 12 months
Change from baseline in triglycerides
Time frame: Baseline, 6 months, and 12 months
Change from baseline in cardiovascular risk score
Time frame: Baseline, 6 months, and 12 months
Number of emergency room visits and hospital admissions
Time frame: Up to 12 months
Number of office visits and home visits
Time frame: Up to 12 months
Change from baseline in the number and doses of drugs for treatment of diabetes
Time frame: Baseline and 12 months
Change from baseline in the number and doses of drugs for treatment of hypertension
Time frame: Baseline and 12 months
Change from baseline in the number and doses of drugs for treatment of dyslipidemia
Time frame: Baseline and 12 months
Participant overall satisfaction level
Time frame: Up to 12 months
Participant compliance with protocol-provided devices
Time frame: Up to 12 months
Number of participants who experienced hypoglycemia
Time frame: Up to 12 months
Number of hypoglycemic episodes
Time frame: Up to 12 months
Number of participants who experienced severe/symptomatic hypoglycemia
Time frame: Up to 12 months
Number of severe/symptomatic hypoglycemic episodes
Time frame: Up to 12 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 24 Jun 2015.
- Derived from this study: PubMed 26154338Nicolucci A, Cercone S, Chiriatti A, Muscas F, Gensini G. A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes. Diabetes Technol Ther. 2015 Aug;17(8):563-70. doi: 10.1089/dia.2014.0355. Epub 2015 Jul 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Home telehealth system in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
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 3 inclusion and 6 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in blood glucose level (time frame: Baseline and 12 months). The study lists 3 primary outcomes in all. 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 NCT02194608, 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 24 Jun 2015.