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mHealth Insulin Titration and Management (iSage)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iSage
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed Type 2 Diabetes, based on the World Health Organization (WHO) criteria, treated with basal insulin
  • HbA1c 8-11% inclusive
  • Glomerular filtration rate (GFR) > 60 ml/min
  • Has an Android or iOS based compatible smartphone (iOS 9.0 or above, Android 4.4 or above)
  • Willing to perform at least 1 fasting finger stick glucose measurements every morning
  • English speaking

Exclusion Criteria:

  • Diagnosis of hypoglycemic unawareness
  • Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment
  • Recent (within the last 6 months)/current use of non-topical steroids
  • Insulin requirements in excess of 1 U/kg per day
  • Use of pioglitazone or another thiazolidinedione (TZD)
  • In the opinion of the provider, HgbA1c goals should be adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

iSage for adjustment of insulin

Conventional management

Arm Description

The provider will prescribe the iSage app to the subject and choose a treatment algorithm within the app to make insulin dose adjustments.

Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet.

Outcomes

Primary Outcome Measures

Concentration of HgbA1c
The investigators will compare changes in HgbA1c from baseline to day 90.
Number of participants meeting HgbA1c <7%
The investigators will calculate the percent of patients achieving HgbA1c <7% at day 90.

Secondary Outcome Measures

Sustained use of the iSage app (iSage group only)
The investigators will compare the percentage of subjects using the app as prescribed versus "dropouts".
Hypoglycemia
The investigators will record the number of episodes of hypoglycemia, to include severity of event, related symptoms, and time of day.

Full Information

First Posted
August 28, 2018
Last Updated
August 4, 2023
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03704103
Brief Title
mHealth Insulin Titration and Management (iSage)
Official Title
mHealth Insulin Titration and Management (iSage)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
August 4, 2023 (Actual)
Study Completion Date
August 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The purpose of this study is to determine the benefits of using the iSage app for basal insulin titration and support. By doing this study the investigators hope to learn whether the app improves the participant's ability to follow his/her healthcare provider's instructions to adjust his/her insulin doses.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iSage for adjustment of insulin
Arm Type
Experimental
Arm Description
The provider will prescribe the iSage app to the subject and choose a treatment algorithm within the app to make insulin dose adjustments.
Arm Title
Conventional management
Arm Type
No Intervention
Arm Description
Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet.
Intervention Type
Other
Intervention Name(s)
iSage
Intervention Description
The provider will choose a treatment algorithm within the iSage app and set the parameters to make insulin dose adjustments no less frequently than every 7 days. The patient is instructed to perform daily fasting glucose measurements and follow the app's recommendations for insulin adjustment.
Primary Outcome Measure Information:
Title
Concentration of HgbA1c
Description
The investigators will compare changes in HgbA1c from baseline to day 90.
Time Frame
90 days
Title
Number of participants meeting HgbA1c <7%
Description
The investigators will calculate the percent of patients achieving HgbA1c <7% at day 90.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Sustained use of the iSage app (iSage group only)
Description
The investigators will compare the percentage of subjects using the app as prescribed versus "dropouts".
Time Frame
90 days
Title
Hypoglycemia
Description
The investigators will record the number of episodes of hypoglycemia, to include severity of event, related symptoms, and time of day.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Healthcare resource utilization
Description
Number of contacts with healthcare resources (including telephone calls), ER visits, clinic visits, hospitalizations
Time Frame
90 days
Title
Diabetes Quality of Life Survey (DQOL)
Description
The investigators will compare DQOL scores from baseline to day 90. The 15-item DQOL Brief Clinical Inventory provides a total health-related quality of life score that predicts self-reported diabetes care behaviors and satisfaction with diabetes control as effectively as the full version of the instrument. Items are scored on a 5-point Likert scale and are of two general formats. One format asks about the frequency of negative impact of diabetes itself or of the diabetes treatment (i.e., "How often do you worry about whether you will pass out?") and provides response options from 1 (never) to 5 (all the time). The second format asks about satisfaction with treatment and quality of life (i.e., "How satisfied are you with the time you spend exercising?") and is scored from 1 (very satisfied) to 5 (very dissatisfied). Higher scores are negatively valanced, indicating problem frequency or dissatisfaction.
Time Frame
90 days
Title
Insulin Treatment Satisfaction Questionnaire (ITSQ)
Description
The investigators will compare ITSQ scores from baseline to day 90. The 22-item ITSQ is applicable to a wide variety of insulin therapies, and measures insulin treatment satisfaction assessing regimen inconvenience, lifestyle flexibility, glycemic control, hypoglycemic control, and satisfaction with the insulin delivery device. The response scale is ordinal, ranging from 1 (extremely satisfied) to 6 (extremely dissatisfied). The ITSQ is scored among 5 content clusters, forming a total ITSQ score between 0% to 100%, where 100% indicates complete satisfaction with insulin treatment.
Time Frame
90 days
Title
iSage Product Satisfaction Survey (iSage group only)
Description
The investigators will assess iSage app ease of use and satisfaction. Survey consists of 3 items. Answer choices range from 1 (strongly disagree) to 5 (strongly agree).
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed Type 2 Diabetes, based on the World Health Organization (WHO) criteria, treated with basal insulin HbA1c 8-11% inclusive Glomerular filtration rate (GFR) > 60 ml/min Has an Android or iOS based compatible smartphone (iOS 9.0 or above, Android 4.4 or above) Willing to perform at least 1 fasting finger stick glucose measurements every morning English speaking Exclusion Criteria: Diagnosis of hypoglycemic unawareness Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment Recent (within the last 6 months)/current use of non-topical steroids Insulin requirements in excess of 1 U/kg per day Use of pioglitazone or another thiazolidinedione (TZD) In the opinion of the provider, HgbA1c goals should be adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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mHealth Insulin Titration and Management (iSage)

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