Insulin Degludec Titration Using Mobile Insulin Dosing System

This is a prospective randomized controlled two-group parallel design intervention trial. The
primary endpoint, change from baseline to week 16 in HbA1c is planned to be tested for
superiority of the Glooko Mobile Insulin Dosing System versus standard of care for insulin
degludec titration - both with treatment of Tresiba® U-200 FlexTouch®. 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. The subjects, will be already on long-acting
insulin or insulin naïve subjects and will be started on long-acting insulin degludec
(Tresiba® U-200 FlexTouch®). The subjects will be randomized into one of the two groups:
Group 1 will receive standard of care using the STEP WISE degludec titration algorithm for
long acting insulin titration. Group 2 will receive standard of care along with treatment
facilitated by Glooko mobile insulin dosing system, using the STEP WISE degludec titration
algorithm. Major study assessment will be conducted at Baseline (Screening & Visit 1), at a
second Visit (Visit 2) after 12 weeks or 3 months and, after 16 weeks or 4 months, a final
set of labs, meter download, and subject surveys will be administered (Exit Labs and Meter
Download), in addition, any interactions and subsequent care plan changes completed by the
HCP during Unscheduled HCP Interactions will be documented. Baseline, Visit 2 and the final
screen/Exit Labs visit will include: blood draw, body weight, and questionnaires.

Inclusion Criteria:

1. 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.

2. Subject 18 and older who has documented type 2 diabetes diagnosis at least 3 months
before the screening

3. Subject has HbA1c >/= 7.5% and
4. 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

5. 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)

6. 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):

1. Condoms, sponge, diaphragm, or intrauterine device;

2. Oral or parenteral contraceptives for 3 months prior to screening visit;

3. Vasectomized partner;

4. Total abstinence from sexual intercourse

7. 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.

8. Subject is currently performing self-monitoring of blood glucose(SMBG)

Exclusion Criteria:

1. Subject has had a severe hypoglycemia episode in the last 90 days

2. Subject has type 1 diabetes

3. Subject does not have access to a Glooko compatible smart device (smartphone or
tablet)

4. Subject must not be using Glooko or any other electronic application for insulin
titration

5. Subject is unable to read and understand English

6. Subject is using short acting or pre-mixed insulin for more than 10 days in the last 3
months

7. Subject is going to initiate short acting insulin prior to the study start

8. Pregnant or breastfeeding women, or the intention of becoming pregnant or not using
adequate contraceptive measures

9. Visual impairment resulting in inability to see application.

10. Use of systemic steroids for one week or more in the last 90 days from screening

11. Unable to meet protocol requirements (performing SMBG, administering insulin)

12. Known hypersensitivity / intolerance to insulin degludec or any of its excipients

13. Participant in another clinical study?

14. 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)

15. Subject has any other condition or event considered exclusionary by the PI