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Personalizing Self-management in Diabetes - Pilot Study

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GlucoType
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus focused on measuring GlucoType, Informatics, Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65 years
  • A diagnosis of Type 2 Diabetes.
  • A participant of the Washington Heights/Inwood Informatics Infrastructure for Comparative Effectiveness Research (WICER), a patient of the AIM clinic, or a patient of a participating Federally Qualified Health Center (FQHC) health center for at least 6 months
  • Has participated in at least one diabetes education session at the participating site in the last 6 months
  • Proficient in either English or Spanish
  • Must own a basic cell phone

Exclusion Criteria:

  • Pregnancy
  • Presence of serious illness (e.g. cancer diagnosis with active treatment, advanced stage heart failure, multiple sclerosis)
  • Presence of cognitive impairment
  • Plans for leaving their healthcare provider in the next 12 months
  • Does not have a computer and/or Internet access

Sites / Locations

  • Clinical Directors Network
  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

Intervention: GlucoType Single arm study; all participants assigned to use the intervention

Outcomes

Primary Outcome Measures

Change in score on Summary of Diabetes Self-Care Activities Questionnaire (SDSCA)
Change in score on Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) - 12-item with 5 sub-scales (diet, exercise, home blood glucose testing, foot care, smoking status). The respondent is asked how many days in the past week he/she performed the behavior (ranges from 0 to 7); higher scores indicates higher performance.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2018
Last Updated
March 27, 2023
Sponsor
Columbia University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04757233
Brief Title
Personalizing Self-management in Diabetes - Pilot Study
Official Title
Dynamically Tailoring Interventions for Problem-Solving in Diabetes Self-Management Using Self-Monitoring Data
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to conduct a pilot feasibility study a novel informatics intervention, GlucoType (also called Platano for Latino users) that incorporates computational analysis of self-monitoring data to help individuals with type 2 diabetes personalize diabetes self-management strategies. This study will include 20 individuals with type 2 diabetes mellitus (T2DM) recruited from economically disadvantaged and medically underserved communities to test Platano for 4 weeks to assess its acceptability and feasibility. The main outcome measures include problem-solving abilities in diabetes (Diabetes Problem-Solving Inventory (DPSA)) and self-reported diabetes self-care (Summary of Diabetes Self-Care Activities Questionnaire (SDSCA)). In addition, this study will include a controlled laboratory experiment to assess whether participants can understand and follow personalized nutritional goals generated by Platano.
Detailed Description
Growing evidence highlights significant differences in individuals' physiology and glycemic function and their cultural, social, and economical circumstances that impact diabetes self-management. These discoveries paved the way for precision medicine-an approach to personalizing medical treatment to an individual's genetic makeup, clinical history, and lifestyle. Computational learning methods have been successfully used for identifying clinical phenotypes-observable manifestations of diseases. Studies showed the benefits of tailoring not only medical treatment, but also behavioral interventions; however, tailoring typically relies on expert identification of tailoring variables and decision rules, and on standard surveys. Data collected with self-monitoring can more accurately reflect an individual's behaviors and glycemic patterns, thus highlighting their "behavioral phenotypes", yet such data are rarely utilized in tailoring. The ongoing focus of this research is on facilitating problem-solving in diabetes self-management. Well-developed problem-solving skills are essential to diabetes management result in better diabetes self-care behaviors lead to improvements in clinical outcomes and can be fostered with face-to-face interventions. Previous research suggested problem identification and generation of alternatives as critical steps in problem-solving in diabetes. In previous work, the investigators developed an informatics intervention that relied on expert-generated knowledge for assisting individuals on these steps of problem-solving. In this pilot feasibility study, the investigators study an alternative solution that relies on computational pattern analysis of data collected with self-monitoring technologies to tailor the problem-solving assistance to individuals' unique behavioral phenotypes. The intervention, GlucoType uses computational learning methods to identify systematic patterns in individuals' diet, physical activity, and sleep, captured with custom-built and commercial self-monitoring technologies, and correlates these patterns with fluctuations in individuals' blood glucose levels. GlucoType then uses this information to 1) identify behavioral patterns associated with high glycemic excursion, 2) formulate personalized goals to modify these behaviors, 3) provide in-the-moment decision support to help individuals be more consistent in meeting their goals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
GlucoType, Informatics, Diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
Intervention: GlucoType Single arm study; all participants assigned to use the intervention
Intervention Type
Behavioral
Intervention Name(s)
GlucoType
Intervention Description
GlucoType is an mobile Health intervention for facilitating self-management in T2DM built for iPhone and Android smartphones. GlucoType includes a custom-built interface for low-burden capture of diet and blood glucose (BG) levels and relies on a commercial activity tracker, FitBit, for capture of sleep and physical activity. It then applies computational phenotyping techniques to identify patterns of associations between daily activities and changes in BG levels. GlucoType uses an expert system developed by our research team to translate identified phenotypes into automatically-generated personalized behavioral goals for improving glycemic control formulated in natural language.
Primary Outcome Measure Information:
Title
Change in score on Summary of Diabetes Self-Care Activities Questionnaire (SDSCA)
Description
Change in score on Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) - 12-item with 5 sub-scales (diet, exercise, home blood glucose testing, foot care, smoking status). The respondent is asked how many days in the past week he/she performed the behavior (ranges from 0 to 7); higher scores indicates higher performance.
Time Frame
From Baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 years A diagnosis of Type 2 Diabetes. A participant of the Washington Heights/Inwood Informatics Infrastructure for Comparative Effectiveness Research (WICER), a patient of the AIM clinic, or a patient of a participating Federally Qualified Health Center (FQHC) health center for at least 6 months Has participated in at least one diabetes education session at the participating site in the last 6 months Proficient in either English or Spanish Must own a basic cell phone Exclusion Criteria: Pregnancy Presence of serious illness (e.g. cancer diagnosis with active treatment, advanced stage heart failure, multiple sclerosis) Presence of cognitive impairment Plans for leaving their healthcare provider in the next 12 months Does not have a computer and/or Internet access
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olena Mamykina, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Directors Network
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26590418
Citation
Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.
Results Reference
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PubMed Identifier
23264420
Citation
Haas L, Maryniuk M, Beck J, Cox CE, Duker P, Edwards L, Fisher EB, Hanson L, Kent D, Kolb L, McLaughlin S, Orzeck E, Piette JD, Rhinehart AS, Rothman R, Sklaroff S, Tomky D, Youssef G; 2012 Standards Revision Task Force. National standards for diabetes self-management education and support. Diabetes Care. 2013 Jan;36 Suppl 1(Suppl 1):S100-8. doi: 10.2337/dc13-S100. No abstract available.
Results Reference
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PubMed Identifier
25635347
Citation
Collins FS, Varmus H. A new initiative on precision medicine. N Engl J Med. 2015 Feb 26;372(9):793-5. doi: 10.1056/NEJMp1500523. Epub 2015 Jan 30.
Results Reference
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Citation
Hastie T, Tibshirani R, Friedman J. The Elements of Statistical Learning [Internet]. New York, NY: Springer New York; 2009 [cited 2016 Jun 4]. (Springer Series in Statistics)
Results Reference
background
PubMed Identifier
25911572
Citation
Liao KP, Cai T, Savova GK, Murphy SN, Karlson EW, Ananthakrishnan AN, Gainer VS, Shaw SY, Xia Z, Szolovits P, Churchill S, Kohane I. Development of phenotype algorithms using electronic medical records and incorporating natural language processing. BMJ. 2015 Apr 24;350:h1885. doi: 10.1136/bmj.h1885.
Results Reference
background
PubMed Identifier
22955496
Citation
Hripcsak G, Albers DJ. Next-generation phenotyping of electronic health records. J Am Med Inform Assoc. 2013 Jan 1;20(1):117-21. doi: 10.1136/amiajnl-2012-001145. Epub 2012 Sep 6.
Results Reference
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Personalizing Self-management in Diabetes - Pilot Study

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