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mHealth Insulin Titration and Management (iSage)

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University of Kansas

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Other: iSage

Study type

Interventional

Funder types

Other

Identifiers

NCT03704103
STUDY00142758

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

21+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

6 participants in 2 patient groups

iSage for adjustment of insulin
Experimental group
Description:
The provider will prescribe the iSage app to the subject and choose a treatment algorithm within the app to make insulin dose adjustments.
Treatment:
Other: iSage
Conventional management
No Intervention group
Description:
Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet.

Trial contacts and locations

1

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Central trial contact

Michelle Vitztum, MPH

Data sourced from clinicaltrials.gov

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