Clinical trial NCT03091712: Insulin Degludec Titration Using Mobile Insulin Dosing System
Official title: Insulin Degludec Titration Using Mobile Insulin Dosing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Degludec
MIDS
Mobile Insulin Dosing System
Glooko
Tresiba
Tresiba® U-200 FlexTouch®
Lead sponsor: Glooko
Sponsor class: INDUSTRY
First posted: 2017-03-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, open label, randomized, controlled, parallel intervention study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 \</=12.5 % measured using a NGSP certified method
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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Week 16
Secondary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Week 12
measure: Proportion of synced BG readings < 54 mg/dL
timeFrame: Week 16
measure: Proportion of synced BG readings < 70 mg/dL
timeFrame: Week 16
measure: Proportion of synced BG readings >250 mg/dL
timeFrame: Week 16
measure: Proportion of synced BG readings in target range (80-180mg/dL)
timeFrame: Week 16
measure: Change in avg BG between first month and last month of study period
timeFrame: Baseline and Week 16
measure: Number of visits to Health Care Professional (HCP) outside of the study visits during study period
timeFrame: Week 16
measure: Number of telephone calls to HCP for insulin titration during study period
timeFrame: Week 16
measure: Total insulin degludec dose
timeFrame: Week 12 and Week 16
measure: Change from baseline in Hypoglycemia fear survey- II response
timeFrame: Week 16
measure: Change from baseline in Diabetes Distress Scale (DDS) response
timeFrame: week 16
measure: Change from baseline in Diabetes treatment satisfaction questionnaire (DTSQ) response
timeFrame: week 16
measure: Number of days with at least one BG test
timeFrame: week 16
measure: Change from baseline in Body weight
timeFrame: week 16
measure: Number of Adverse events during study period
timeFrame: week 16
measure: Number of Serious adverse events during study period
timeFrame: week 16
measure: Correlation of number of dose adjustment completions to change in HbA1c
timeFrame: week 16
measure: Number of subjects that have attained an avg fasting blood glucose target range for at least three of last five titration cycles of study period during trial
timeFrame: week 16
measure: Number of dose adjustments to first reach avg FBG target range during study period
timeFrame: week 16
measure: Total insulin degludec dose for subjects who reached avg FBG target at last dose checkup.
timeFrame: week 16
measure: Frequency of FBG tests during study period
timeFrame: week 16
measure: Proportion of accepted MIDS recommended insulin degludec doses
timeFrame: week 16
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Glooko
name: Michael Greenfield, MD
role: STUDY_DIRECTOR
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