[Federal Register Volume 82, Number 156 (Tuesday, August 15, 2017)]
[Notices]
[Pages 38691-38692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Mobile Health 
Technology for Diabetes

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Request for supplemental evidence and data submissions.

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SUMMARY: The Agency for Healthcare Research and Quality is seeking 
scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Mobile Health 
Technology for Diabetes, which is currently being conducted by the 
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before September 14, 2017.

ADDRESSES: 

Email submissions: <a href="/cdn-cgi/l/email-protection#0d5e484c495e4d687d6e20316c2d657f686b30" http: src.org">src.org</a>">SEADS@epc-src.org</a>.
Print submissions:
Mailing Address: Portland VA Research Foundation, Scientific Resource 
Center, ATTN: Scientific Information Packet Coordinator, P.O. Box 
69539, Portland, OR 97239
Shipping Address (FedEx, UPS, etc.): Portland VA Research Foundation,

[[Page 38692]]

Scientific Resource Center, ATTN: Scientific Information Packet 
Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 71, 
Portland, OR 97239

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 51723 or Email: <a href="/cdn-cgi/l/email-protection#c2918783869182a7b2a1effea3e2aab0a7a4ff" http: src.org">src.org</a>">SEADS@epc-src.org</a>.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality (AHRQ) has commissioned the Evidence-based Practice Centers 
(EPC) Program to complete a review of the evidence for Mobile Health 
Technology for Diabetes. AHRQ is conducting this systematic review 
pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 
299a(a).
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Mobile Health Technology for Diabetes, including those 
that describe adverse events. The entire research protocol, including 
the key questions, is also available online at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=2484.
    This is to notify the public that the EPC Program would find the 
following information on Mobile Health Technology for Diabetes helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, please provide a summary, including the following 
elements: Study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC Program. 
Materials submitted must be publicly available or able to be made 
public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

The Guiding Questions

    I. Which specific mobile health technology (mHealth) technologies 
for diabetes self-management have been researched?
    II. What are the characteristics (e.g., interoperability, 
functions, acceptability/usability, connection to electronic health 
records) of these specific mHealth technologies?
    III. What patient outcomes are associated with the use of these 
specific mHealth technologies?
    IV. What are the harms and costs associated with these specific 
mHealth technologies?

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-17152 Filed 8-14-17; 8:45 am]
BILLING CODE 4160-90-P


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