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

March 19, 2015 updated by: Medidata Solutions
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33143
        • Miami Research Associates (MRA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects, aged 18 to 60 years, who are English or Spanish speakers.
  2. BMI 25 to 34.9 kg/m2
  3. Subject has type 2 diabetes with HgbA1c < 8.0%
  4. 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).
  5. Subject is motivated to increase their activity and make other lifestyle changes.

  6. Subject has:

    • 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
  7. Female subject is surgically sterile, post-menopausal or agrees to use an acceptable method of birth control as defined in section 2.7.
  8. Subject agrees to not use any new vitamin and/or mineral supplement until after study completion.
  9. 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.

  10. Subject is willing and able to comply with the protocol including:

    1. Attending 3 visits, approximately 2 hours each
    2. Wearing and inputting required information into the Fitbit Flex activity tracker
    3. Receiving alerts from the Medidata Patient Cloud
    4. Working on making nutrition and exercise changes over the 8-week study period
    5. 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).
  11. Subject is able to understand and sign the informed consent to participate in the study.

Exclusion Criteria:

  1. Subject has any of the following medical conditions:

    1. active heart disease
    2. uncontrolled high blood pressure (≥ 140/90 mmHg)
    3. renal or hepatic impairment/disease
    4. Type I diabetes
    5. bipolar disorder
    6. active psychiatric disease
    7. Parkinson's disease
    8. unstable thyroid disease
    9. immune disorder (such as HIV/AIDS)
    10. any medical condition deemed exclusionary by the Principal Investigator (PI)
  2. Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
  3. Subject is taking oral agents that can cause hypoglycemia (e.g. sulfonylureas, meglitinides and insulin).
  4. 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.
  5. Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
  6. Subject is currently taking any medication deemed exclusionary by PI.
  7. 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.
  8. Subject has a clinically relevant abnormality as defined by the PI or interpreting physician with respect to the electrocardiogram (ECG).
  9. Subject has a QTc interval > 450 msec for males and > 470 msec for females.
  10. Subject has a history of drug or alcohol abuse in the past 12 months.
  11. Subject has begun/stopped smoking ≤ 6 months ago OR has plans to begin/quit smoking.
  12. Subject has experienced a weight loss or gain greater than 4.5 kg (approximately 10 lbs) in the past 3 months.
  13. Subject is pregnant, lactating, or planning to become pregnant during the study period.
  14. 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.
  15. Subject has taken an investigational product within 30 days of study enrollment (visit 2).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lifestyle counseling
Behavioral: lifestyle modification instructional and motivational sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline to 8 weeks in glucose, insulin, fructosamine and HgbA1c
Time Frame: 8 weeks
8 weeks
Changes from baseline to 4 and 8 weeks in body weight.
Time Frame: 4 to 8 weeks
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
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
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
8 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Changes from baseline to 4 and 8 weeks on quality of sleep as measured via the sleep efficiency score (provided by the Fitbit Flex).
Time Frame: 4 to 8 weeks
4 to 8 weeks
Changes from baseline to 4 and 8 weeks in compliance with exercise goals as measured by active minutes (provided by the Fitbit Flex; requires subject input of data).
Time Frame: 4 to 8 weeks
4 to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medidata Solutions

Collaborators

Miami Research Associates

Investigators

  • Principal Investigator: Diane R. Krieger, MD, Miami Research Associates. Miami, FL.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOVE-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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