Insulin Degludec Titration Using Mobile Insulin Dosing System
Completed · Not applicable
Conditions studied: Type 2 Diabetes Mellitus
In brief
This is an open label randomized, controlled, parallel intervention study. Group 1 will receive usual care for insulin degludec titration using the STEP WISE degludec titration algorithm Group 2 will receive Glooko mobile insulin dosing system, using the STEP WISE degludec titration algorithm.An estimated n= 240 subjects with type 2 diabetes will be enrolled in order to obtain approximately 200 evaluable subjects who will complete the 16 week study.
Key facts
- Study ID
- NCT03091712
- Run by
- Glooko
- People needed
- 240
- Starts
- 2017-05-05
- Expected to finish
- 2019-09-15
- Last updated by the study team
- 2020-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject has the ability to sign an informed consent form. Prior to randomization patients has signed the informed consent, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
- Subject 18 and older who has documented type 2 diabetes diagnosis at least 3 months before the screening
- Subject has HbA1c >/= 7.5% and </=12.5 % measured using a NGSP certified method
- Subject is initiating basal insulin therapy with insulin degludec or switching to insulin degludec from any basal insulin. The subject may also be on concomitant anti-hyperglycemic agents, including oral hypoglycemic (OAs), non-insulin injectables (e.g. GLP-1) which has been at a stable dose for approx. 3 months, or as determined by the Investigator
- Subject is a male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
- If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study):
- Condoms, sponge, diaphragm, or intrauterine device;
- Oral or parenteral contraceptives for 3 months prior to screening visit;
- Vasectomized partner;
- Total abstinence from sexual intercourse
- Subject has a Glooko compatible smart device (smartphone/tablet) with an active data plan or access to Wi-Fi and downloaded at least one mobile application on their phone on their own. If subject does not have a Glooko compatible smart device, a loaner smart device can be provided for the study period.
- Subject is currently performing self-monitoring of blood glucose(SMBG)
You may not qualify if…
- Subject has had a severe hypoglycemia episode in the last 90 days
- Subject has type 1 diabetes
- Subject does not have access to a Glooko compatible smart device (smartphone or tablet)
- Subject must not be using Glooko or any other electronic application for insulin titration
- Subject is unable to read and understand English
- Subject is using short acting or pre-mixed insulin for more than 10 days in the last 3 months
- Subject is going to initiate short acting insulin prior to the study start
- Pregnant or breastfeeding women, or the intention of becoming pregnant or not using adequate contraceptive measures
- Visual impairment resulting in inability to see application.
- Use of systemic steroids for one week or more in the last 90 days from screening
- Unable to meet protocol requirements (performing SMBG, administering insulin)
- Known hypersensitivity / intolerance to insulin degludec or any of its excipients
- Participant in another clinical study?
- In the opinion of the PI, if the subject is already on insulin and cannot be properly managed with only long acting insulin (e.g., the introduction of meal time insulin is necessary)
- Subject has any other condition or event considered exclusionary by the PI
Where it is running
- Scripps Whittier Diabetes Institute — San Diego, California, United States
Full record on ClinicalTrials.gov
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