Type 1 DiabetesNCT01341587
Smart Glucose Meter Project
A study testing Telcare Blood Glucose Meter (BGM) in people with Type 1 Diabetes and Type 2 Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Currently, in the U.S., 1 in 3 males and 2 in 5 females born after 2000 are expected to develop diabetes during his or her lifetime. Research has demonstrated that control of blood glucose (BG) reduces the complications of diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Telcare Blood Glucose Meter (BGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Diagnosis of Diabetes Mellitus (Type 1 or Type 2)
- Currently, non-compliant with prescribed glucose testing regimen
- HbA1c of 7.5 or greater within the last six months
Who cannot join
- Actively being treated for substance abuse
- Treatment for a thought disorder within the past year
- Non-English speaking
- Persons who are legally blind
- Women who are pregnant
- Cognitively or decisionally impaired as determined by practitioner
- Persons using an insulin pump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Cellular-embedded Glucose Meter With Two-way Personalized Communication Between Patients and Care Managers With a Glucose Meter in Standard Practice in the Care of Diabetic Patients.
Currently, in the U.S., 1 in 3 males and 2 in 5 females born after 2000 are expected to develop diabetes during his or her lifetime. Research has demonstrated that control of blood glucose (BG) reduces the complications of diabetes. As a result, almost half of Americans diagnosed with diabetes, are prescribed finger-stick glucose meters to monitor their BG. The value of this approach is known to be limited by a high rate of patient non-compliance with BG testing, where patients test less often than prescribed. Increased communication between patient and care manager along with feedback has been shown to increase self monitoring of blood glucose (SMBG) test compliance. However, this feedback loop is largely absent from the current, episodic model of patient / care manager interaction and not available in existing BG meters given to diabetic patients.
In this study, we propose to pilot test a cellular-embedded glucose meter. This device can transmit glucose readings directly over a cellular network to a care management server and then the patient will receive feedback on the screen of the glucose meter.
Read the detailed description
This research program will enroll participants in a 6-month pilot intervention study. In this study, 100 patients with diabetes (Type 1 and Type 2) who are known to be non-compliant with SMBG will be enrolled and randomized to treatment groups (one group will receive a standard glucose meter and the second group will receive the cellular-embedded device) in order to achieve the following specific study aims;
Primary Aim 1: Determine if connecting diabetic patients to care managers via a cellular-enabled glucose meter with feedback will improve SMBG testing compliance.
Secondary Aim 2: Determine if increased testing compliance leads to improvement in overall blood glucose control. This will be measured by a reduction of HbA1c levels.
Secondary Aim 3: Determine whether this intervention leads to significant improvements in patient satisfaction with self-care and patient self-assessment of compliance.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Telcare Blood Glucose Meter (BGM)
- Keywords
- SMBG (self monitoring of blood glucose), diabetes, mobile technology
- Medical subject headings
- Diabetes Mellitus, Type 1, 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.
Telcare Blood Glucose Meter (BGM)Device
Cellular enabled glucometer
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) |
| Intervention | Active comparator | Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.
Care provider can access raw and analyzed patient data; Physician receives report summary. Receives: Device: Telcare Blood Glucose Meter (BGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months
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 posted25 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: participants lost to follow-up;
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.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Industrial Partnerships, Telcare, Inc
- Responsible party
- Sponsor
- Investigators
- Cindy Geppi, Study director, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341587
- Sponsor's protocol ID
- HP-00045527
- Status last verified
- Dec 2019
- First submitted
- 7 Feb 2011
- Last updated
- 2 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Cellular-embedded Glucose Meter With Two-way Personalized Communication Between Patients and Care Managers With a Glucose Meter in Standard Practice in the Care of Diabetic Patients.
- ClinicalTrials.gov ID
- NCT01341587
- Acronym / sponsor ID
- HP-00045527
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- SMBG (self monitoring of blood glucose), diabetes, mobile technology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: participants lost to follow-up;
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Maryland Industrial Partnerships, Telcare, Inc
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Posted 12 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, in the U.S., 1 in 3 males and 2 in 5 females born after 2000 are expected to develop diabetes during his or her lifetime. Research has demonstrated that control of blood glucose (BG) reduces the complications of diabetes. As a result, almost half of Americans diagnosed with diabetes, are prescribed finger-stick glucose meters to monitor their BG. The value of this approach is known to be limited by a high rate of patient non-compliance with BG testing, where patients test less often than prescribed. Increased communication between patient and care manager along with feedback has been shown to increase self monitoring of blood glucose (SMBG) test compliance. However, this feedback loop is largely absent from the current, episodic model of patient / care manager interaction and not available in existing BG meters given to diabetic patients.
In this study, we propose to pilot test a cellular-embedded glucose meter. This device can transmit glucose readings directly over a cellular network to a care management server and then the patient will receive feedback on the screen of the glucose meter.
Detailed description
This research program will enroll participants in a 6-month pilot intervention study. In this study, 100 patients with diabetes (Type 1 and Type 2) who are known to be non-compliant with SMBG will be enrolled and randomized to treatment groups (one group will receive a standard glucose meter and the second group will receive the cellular-embedded device) in order to achieve the following specific study aims;
Primary Aim 1: Determine if connecting diabetic patients to care managers via a cellular-enabled glucose meter with feedback will improve SMBG testing compliance.
Secondary Aim 2: Determine if increased testing compliance leads to improvement in overall blood glucose control. This will be measured by a reduction of HbA1c levels.
Secondary Aim 3: Determine whether this intervention leads to significant improvements in patient satisfaction with self-care and patient self-assessment of compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) |
| Intervention | Active comparator | Device: Telcare Blood Glucose Meter (BGM)Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback. Care provider can access raw and analyzed patient data; Physician receives report summary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age and older
- Diagnosis of Diabetes Mellitus (Type 1 or Type 2)
- Currently, non-compliant with prescribed glucose testing regimen
- HbA1c of 7.5 or greater within the last six months
Key exclusion criteria (7 listed)
- Actively being treated for substance abuse
- Treatment for a thought disorder within the past year
- Non-English speaking
- Persons who are legally blind
- Women who are pregnant
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 |
|---|---|---|
| Telcare Blood Glucose Meter (BGM)Cellular enabled glucometer | Device | Intervention |
Primary outcome
Change in HbA1c
Time frame: 6 months
Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Type 1 Diabetes
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
RecruitingObservational study
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Type1diabetes
RecruitingPhase 2
Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
Colon Cancer
Active, not recruitingObservational study
Epidemiology of Diabetes Interventions and Complications (EDIC)
Type 1 Diabetes Mellitus
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
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.
Cindy Geppi study director
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telcare Blood Glucose Meter (BGM) in people with Type 1 Diabetes and Type 2 Diabetes, run by University of Maryland, Baltimore 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 4 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: stopped early, as of the sponsor's last update on 2 Jun 2023. 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 12 Mar 2018). 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: 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 Jun 2023.