Type 2 Diabetes MellitusNCT02227303
A Pilot Open Label Clinical Trial to Evaluate the Combined Impact of Two Mobile Health Products on Health Outcomes in Overweight Adults With Type 2 Diabetes
A study testing lifestyle modification instructional and motivational sessions in people with Type 2 Diabetes Mellitus, run by Medidata Solutions at 1 site in United States.
Trial summary
The purpose of this study is to explore the effect of 8-weeks use of the Medidata Patient Cloud (a mobile application for capturing data directly from subjects, enabling entry of diary and quality of life data into internet-enabled devices) in combination with an activity tracker (Fitbit Flex) on health outcomes in… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- lifestyle modification instructional and motivational sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Mar 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects, aged 18 to 60 years, who are English or Spanish speakers.
- BMI 25 to 34.9 kg/m2
- Subject has type 2 diabetes with HgbA1c < 8.0%
- Subject's glucose is controlled with either diet alone or oral agents that do not cause hypoglycemia (e.g. Metformin, DPP-4 inhibitors, Thiazolidinediones, Alpha-Glucosidase Inhibitors and GLP-1 agonists).
- Subject is motivated to increase their activity and make other lifestyle changes.
- Subject has:
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- A compatible Apple mobile device with the iOS 7 operating system installed:
- iPhone 4 or newer
- iPad 2 or newer
- iPad Mini
- iPod touch 5th gen (2012 model) or newer
- 500MB of free space on the iPhone, iPad, or iPod touch
- A valid mobile phone number to receive daily updates via SMS text messaging
- An active iTunes account/password to install study-related software ("apps")
- Access to Wi-Fi or a mobile data plan to send study data
- Female subject is surgically sterile, post-menopausal or agrees to use an acceptable method of birth control as defined in section 2.7.
- Subject agrees to not use any new vitamin and/or mineral supplement until after study completion.
- Subject agrees to not take any dietary or herbal supplements or products until after study completion. Seven-day washout period prior to study inclusion allowed.
- Subject is willing and able to comply with the protocol including:
- Attending 3 visits, approximately 2 hours each
- Wearing and inputting required information into the Fitbit Flex activity tracker
- Receiving alerts from the Medidata Patient Cloud
- Working on making nutrition and exercise changes over the 8-week study period
- Using and updating his/her iPhone, iPad, iPad Mini or iTouch as per study requirements (e.g. downloading the iOS7 operating system, downloading the Medidata Patient Cloud and Fitbit Flex apps, and receiving daily text messages).
- Subject is able to understand and sign the informed consent to participate in the study.
Who cannot join
- Subject has any of the following medical conditions:
- active heart disease
- uncontrolled high blood pressure (≥ 140/90 mmHg)
- renal or hepatic impairment/disease
- Type I diabetes
- bipolar disorder
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- active psychiatric disease
- Parkinson's disease
- unstable thyroid disease
- immune disorder (such as HIV/AIDS)
- any medical condition deemed exclusionary by the Principal Investigator (PI)
- Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
- Subject is taking oral agents that can cause hypoglycemia (e.g. sulfonylureas, meglitinides and insulin).
- Subject is taking or has taken in the past 28 days any supplement or medication (prescription or over the counter) for weight loss (see section 2.6.2); 28-day washout required for study inclusion.
- Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
- Subject is currently taking any medication deemed exclusionary by PI.
- Subject exhibits evidence of hepatic or renal dysfunction as evidenced by ALT, AST, AP being ≥ 2 times the upper limit of normal or serum creatinine value ≥ 2.0 mg/dl or other clinically significant abnormal clinical laboratory value per PI discretion.
- Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the electrocardiogram (ECG).
- Subject has a QTc interval > 450 msec for males and > 470 msec for females.
- Subject has a history of drug or alcohol abuse in the past 12 months.
- Subject has begun/stopped smoking ≤ 6 months ago OR has plans to begin/quit smoking.
- Subject has experienced a weight loss or gain greater than 4.5 kg (approximately 10 lbs) in the past 3 months.
- Subject is pregnant, lactating, or planning to become pregnant during the study period.
- Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
- Subject has taken an investigational product within 30 days of study enrollment (visit 2).
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Research Associates (MRA)
Miami, Florida, 33143
About this study
The purpose of this study is to explore the effect of 8-weeks use of the Medidata Patient Cloud (a mobile application for capturing data directly from subjects, enabling entry of diary and quality of life data into internet-enabled devices) in combination with an activity tracker (Fitbit Flex) on health outcomes in overweight people with Type 2 Diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- lifestyle modification instructional and motivational sessions
- 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.
lifestyle modification instructional and motivational sessionsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Other | Not described Receives: Behavioral: lifestyle modification instructional and motivational sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to 8 weeks in glucose, insulin, fructosamine and HgbA1c
Measured: 8 weeks
Changes from baseline to 4 and 8 weeks in body weight.
Measured: 4 to 8 weeks
Changes from baseline to 4 and 8 weeks in compliance with nutrition goals as measured via dichotomous questionnaire.
Measured: 4 to 8 weeks
Changes from baseline to 4 and 8 weeks in compliance with exercise goals as measured by steps per day (provided by the Fitbit Flex).
Measured: 4 to 8 weeks
Weekly changes over 8 weeks as compared to baseline in quality of life as measured by the PROMIS® Global Health questionnaire (global physical health and global mental health subscale scores and social and overall health scores).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medidata Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Miami Research Associates
- Responsible party
- Sponsor
- Investigators
- Diane R. Krieger, MD, Principal investigator, Miami Research Associates. Miami, FL.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227303
- Sponsor's protocol ID
- MOVE-2014
- Status last verified
- Mar 2015
- First submitted
- 25 Aug 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Evert AB, Boucher JL, Cypress M, Dunbar SA, Franz MJ, Mayer-Davis EJ, Neumiller JJ, Nwankwo R, Verdi CL, Urbanski P, Yancy WS Jr. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2014 Jan;37 Suppl 1:S120-43. doi: 10.2337/dc14-S120. No abstract available.
PubMed 24357208Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Open Label Clinical Trial to Evaluate the Combined Impact of Two Mobile Health Products on Health Outcomes in Overweight Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02227303
- Acronym / sponsor ID
- MOVE-2014
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medidata SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Miami Research Associates
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Aug 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 purpose of this study is to explore the effect of 8-weeks use of the Medidata Patient Cloud (a mobile application for capturing data directly from subjects, enabling entry of diary and quality of life data into internet-enabled devices) in combination with an activity tracker (Fitbit Flex) on health outcomes in overweight people with Type 2 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Other | Behavioral: lifestyle modification instructional and motivational sessions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- Male and female subjects, aged 18 to 60 years, who are English or Spanish speakers.
- BMI 25 to 34.9 kg/m2
- Subject has type 2 diabetes with HgbA1c < 8.0%
- Subject's glucose is controlled with either diet alone or oral agents that do not cause hypoglycemia (e.g. Metformin, DPP-4 inhibitors, Thiazolidinediones, Alpha-Glucosidase Inhibitors and GLP-1 agonists).
- Subject is motivated to increase their activity and make other lifestyle changes.
Key exclusion criteria (25 listed)
- Subject has any of the following medical conditions:
- Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
- Subject is taking oral agents that can cause hypoglycemia (e.g. sulfonylureas, meglitinides and insulin).
- Subject is taking or has taken in the past 28 days any supplement or medication (prescription or over the counter) for weight loss (see section 2.6.2); 28-day washout required for study inclusion.
- Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
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 |
|---|---|---|
| lifestyle modification instructional and motivational sessions | Behavioural | Lifestyle counseling |
Primary outcome
Changes from baseline to 8 weeks in glucose, insulin, fructosamine and HgbA1c
Time frame: 8 weeks
Changes from baseline to 4 and 8 weeks in body weight.
Time frame: 4 to 8 weeks
Changes from baseline to 4 and 8 weeks in compliance with nutrition goals as measured via dichotomous questionnaire.
Time frame: 4 to 8 weeks
Changes from baseline to 4 and 8 weeks in compliance with exercise goals as measured by steps per day (provided by the Fitbit Flex).
Time frame: 4 to 8 weeks
Weekly changes over 8 weeks as compared to baseline in quality of life as measured by the PROMIS® Global Health questionnaire (global physical health and global mental health subscale scores and social and overall health scores).
Time frame: 8 weeks
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 Mar 2015.
- Background: PubMed 24357208Evert AB, Boucher JL, Cypress M, Dunbar SA, Franz MJ, Mayer-Davis EJ, Neumiller JJ, Nwankwo R, Verdi CL, Urbanski P, Yancy WS Jr. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2014 Jan;37 Suppl 1:S120-43. doi: 10.2337/dc14-S120. No abstract available.
- Background: PubMed 8628042Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
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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.
Diane R. Krieger, MD principal investigator
Miami Research Associates. Miami, FL.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle modification instructional and motivational sessions in people with Type 2 Diabetes Mellitus, run by Medidata Solutions 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 25 inclusion and 25 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 Mar 2015. 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?
Changes from baseline to 8 weeks in glucose, insulin, fructosamine and HgbA1c (time frame: 8 weeks). The study lists 5 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 NCT02227303, 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 24 Mar 2015.