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

NCT02227303 | Completed

• 1 other identifier: MOVE-2014
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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 overweight people with Type 2 Diabetes.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• Changes from baseline to 8 weeks in glucose, insulin, fructosamine and HgbA1c

  8 weeks

• Changes from baseline to 4 and 8 weeks in body weight.

  4 to 8 weeks

• Changes from baseline to 4 and 8 weeks in compliance with nutrition goals as measured via dichotomous questionnaire.

  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).

  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).

  8 weeks

Other Outcomes (2)

• Changes from baseline to 4 and 8 weeks on quality of sleep as measured via the sleep efficiency score (provided by the Fitbit Flex).

  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).

  4 to 8 weeks

Study Arms (1)

Lifestyle counseling

OTHER

Behavioral: lifestyle modification instructional and motivational sessions

Interventions

lifestyle modification instructional and motivational sessions BEHAVIORAL

Lifestyle counseling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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
• MB 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

You may not qualify if:

• 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
• active psychiatric disease
• Parkinson's disease
• unstable thyroid disease
• immune disorder (such as HIV/AIDS)
• 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 on an unstable dose of medication (defined as fewer than 90 days at the same dose).
• 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).

Sponsors & Collaborators

• Medidata Solutions: lead
• Miami Research Associates: collaborator

Study Sites (1)

Miami Research Associates (MRA)

Miami, Florida, 33143, United States

Location

Related Publications (3)

• 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.

  PMID: 24357208 BACKGROUND

• Ware 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.

  PMID: 8628042 BACKGROUND

• Faul 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.

  PMID: 17695343 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Diane R. Krieger, MD

  Miami Research Associates. Miami, FL.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 28, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

US (1)