DiabetesTELEGAPNCT01775878
Diabetes Care Management Trial of Telemetric Monitoring
A study testing Telemonitoring Device in people with Diabetes, run by Kaiser Permanente.
Trial summary
The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Telemonitoring Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jan 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 75 years old,
- diagnosis of type 2 diabetes mellitus for at least 1 month,
- eligible for and referred to the diabetes care management program,
- HbA1c values in the range: 7.5% to 10.5%.
Who cannot join
- Weight > 330 lbs,
- estimated glomerular filtration rate (GFR) < 45,
- unstable coronary artery disease,
- severe peripheral vascular disease which restricted exercise,
- end-stage liver disease,
- undergoing treatment for cancer,
- pregnant or not using appropriate birth control,
- no broadband internet access in their homes.
About this study
Official title: A Randomized Study Comparing Usual Diabetes Care Management to Telemetric Home-based Monitoring of Glucose and Blood Pressure in Patients With Diabetes (TELEGAP)
The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be randomly assigned to one of two treatment arms. The telemedicine group or the group receiving usual care (the control group).
This study hopes to show the usefulness of this telemonitoring technology and more specifically, to assess whether this device improves markers of control of diabetes, glycemic control, and cardiovascular risk factors
- Conditions
- Diabetes
- Being tested
- Telemonitoring Device
- Keywords
- Diabetes, HbA1c, Fructosamine, Blood Pressure, Telemonitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring DeviceDevice
Also called Samsung Health Diary
Telemonitoring device was installed in patients' homes
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | This arm received usual care from the diabetes care managers |
| Telemonitoring Device | Experimental | Patients in this arm received a telemonitoring device installed in their homes Receives: Device: Telemonitoring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fructosamine
Change from baseline to 6 weeks in serum fructosamine levels
Measured: 6 weeks
glycosylated hemoglobin
change from baseline to 6 months in serum HbA1c levels
Measured: 6 months
Secondary outcomes (1)
blood pressure
goal of systolic < 130 mmHg and diastolic < 70 mmHg
Measured: 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startMay 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Sponsor
- Investigators
- Jerry Minkoff, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775878
- Sponsor's protocol ID
- CN-08JMink-01
- Acronym
- TELEGAP
- Status last verified
- Jan 2013
- First submitted
- 23 Jan 2013
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Usual Diabetes Care Management to Telemetric Home-based Monitoring of Glucose and Blood Pressure in Patients With Diabetes (TELEGAP)
- ClinicalTrials.gov ID
- NCT01775878
- Acronym / sponsor ID
- TELEGAP / CN-08JMink-01
- Conditions
- Diabetes
- Keywords
- Diabetes, HbA1c, Fructosamine, Blood Pressure, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- May 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 Jan 2013 (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 study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be randomly assigned to one of two treatment arms. The telemedicine group or the group receiving usual care (the control group).
This study hopes to show the usefulness of this telemonitoring technology and more specifically, to assess whether this device improves markers of control of diabetes, glycemic control, and cardiovascular risk factors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –This arm received usual care from the diabetes care managers |
| Telemonitoring Device | Experimental | Device: Telemonitoring DevicePatients in this arm received a telemonitoring device installed in their homes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 75 years old,
- diagnosis of type 2 diabetes mellitus for at least 1 month,
- eligible for and referred to the diabetes care management program,
- HbA1c values in the range: 7.5% to 10.5%.
Key exclusion criteria (8 listed)
- Weight > 330 lbs,
- estimated glomerular filtration rate (GFR) < 45,
- unstable coronary artery disease,
- severe peripheral vascular disease which restricted exercise,
- end-stage liver disease,
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 |
|---|---|---|
| Telemonitoring DeviceAlso: Samsung Health DiaryTelemonitoring device was installed in patients' homes | Device | Telemonitoring Device |
Primary outcome
Fructosamine
Time frame: 6 weeks
Change from baseline to 6 weeks in serum fructosamine levels
glycosylated hemoglobin
Time frame: 6 months
change from baseline to 6 months in serum HbA1c levels
1 secondary outcome
blood pressure
Time frame: 6 weeks and 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 25 Jan 2013.
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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.
Jerry Minkoff, MD principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring Device in people with Diabetes, run by Kaiser Permanente.
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 4 inclusion and 8 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 25 Jan 2013. 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?
Fructosamine (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 25 Jan 2013.