Diabetes Mellitus, Type 2, Diabetic Complication
Conditions
Brief summary
The principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, FDA-cleared smartphone-based insulin titration application connected to Bluetooth enabled glucose meters. iSage Rx (isageapp.com) allows providers to prescribe basal insulin treatment plans to patients and manages basal insulin doses utilizing clinically proven algorithms. In this pilot study, we hypothesize that this user-friendly application and seamless data capture will improve glycemic control (achieve HgbA1c \<7%) and reduce the frequency and severity of hypoglycemia. Exploratory measures will include healthcare resource utilization and patient and provider satisfaction. The basal insulin titration algorithms used in iSage have had thousands of user-years' experience in FDA-mandated, closely supervised clinical trials, both for long-acting insulins (e.g., Lantus, Levemir) that have been available for a long time and for the newer ultra-long-acting ones (e.g., Tresiba, Toujeo). However, the effectiveness of iSage with a connected glucose meter has not been studied in a real world clinical environment. Broad use of such an application and connected devices will, we believe, prove to be cost-effective, favor early and appropriate prescription of insulin, reduce provider effort, shorten time to achieve glycemic goals, and simplify the transition to basal insulin therapy.
Interventions
DEVICEiSage App with connected glucometer
Providers prescribe an insulin dosing plan to patients and provide them with a connected glucometer. The patient's plan is administered through a mobile application. In addition, patients receive education and guidance on insulin administration.
BEHAVIORALMagnet
Patients are given a refrigerator magnet with an insulin titration algorithm and are asked to follow the instructions on the magnet.
Sponsors
Kansas City Area Life Sciences Institute, Inc.
University of Kansas
LifeScan
Amalgam Rx, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* T2DM (WHO criteria) treated with basal insulin (glargine, detemir, degludec) * HgbA1c 8 or above * GFR \>60 ml/min within the last 12 months * English speaking, informed consent * Has an Android or iOS based compatible smartphone (iOS 9.0 or above; Android 4.4 or above) * Currently performs at least 3 fasting fingerstick glucose measurements/week * Have a PCP within the KU Health System
Exclusion criteria
* Diagnosis of hypoglycemic unawareness within 6 months of enrollment * 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 1U/kg per day * Use of pioglitazone or another thiazolidinedione (TZD) * In the opinion of the provider, HgbA1c goals should adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1C | 3 Months | Mean and Median Change from Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A1C in Target | Baseline to 3 months | Percentage of patients with an A1C \< 7 |
| Rate of Hypoglycemia | Baseline to 3 months | Percentage of glucose readings \<70 |
Countries
United States
Outcome results
None listed