Insulin Degludec Titration Using Mobile Insulin Dosing System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Insulin Degludec Titration Using Mobile Insulin Dosing System

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: Glooko Mobile Insulin Dosing System(MIDS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, open label, randomized, controlled, parallel intervention study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paper Titration Tool and Glooko MIDS<br>Glooko mobile insulin dosing system(MIDS), using the STEP WISE degludec titration algorithm. The eligible subjects will be started on insulin degludec (Tresiba® U-200 FlexTouch®). Subjects will use MIDS for insulin degludec titration management. The clinician will configure MIDS Prescription Instruction Form(PIF) using pre-configured Novo Nordisk, Tresiba Protocol Dosing Treatment Plan which is based on the Novo Tresiba degludec Stepwise Program. The Clinician can alter this as appropriate based on medical judgment. Subjects will be started on MIDS and trained on use of Glooko MIDS mobile app. Subjects will get dose adjustment check up on the app and also alert to contact physician if subject experiences hyperglycemia or hypoglycemia. | Device: Glooko Mobile Insulin Dosing System(MIDS)<br>* Mobile Insulin Dosing System (MIDS) for all long acting insulin degludec titration management<br>|
| No Intervention: Paper Titration tool<br>Usual care for insulin degludec (Tresiba® U-200 FlexTouch® pens) titration using the STEP WISE degludec titration algorithm.The eligible subjects will be started on insulin degludec(Tresiba® U-200 FlexTouch®). Subjects in this group will be provided with a one-page description of the pre-configured Novo Nordisk, Tresiba Protocol Dosing Treatment Plan which is based on the Novo Tresiba degludec Stepwise Program and how to follow it. The Clinician can alter this as appropriate based on medical judgment. This document will also include instructions to contact the HCP if the subject experiences hyperglycemia or hypoglycemia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Change in HbA1c at 16 weeks from baseline for all subjects that adhere to treatment. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c | Change from baseline in HbA1c | Week 12 | 
| Proportion of synced BG readings < 54 mg/dL | Proportion of synced BG readings < 54 mg/dL | Week 16 | 
| Proportion of synced BG readings < 70 mg/dL | Proportion of synced BG readings < 70 mg/dL | Week 16 | 
| Proportion of synced BG readings >250 mg/dL | Proportion of synced BG readings >250 mg/dL | Week 16 | 
| Proportion of synced BG readings in target range (80-180mg/dL) | Proportion of synced BG readings in target range (80-180mg/dL) | Week 16 | 
| Change in avg BG between first month and last month of study period | Change in avg BG between first month and last month of study period | Baseline and Week 16 | 
| Number of visits to Health Care Professional (HCP) outside of the study visits during study period | Number of visits to Health Care Professional (HCP) outside of the study visits during study period | Week 16 | 
| Number of telephone calls to HCP for insulin titration during study period | Number of telephone calls to HCP for insulin titration during study period | Week 16 | 
| Total insulin degludec dose | Total insulin degludec dose | Week 12 and Week 16 | 
| Change from baseline in Hypoglycemia fear survey- II response | Change from baseline in Hypoglycemia fear survey- II response | Week 16 | 
| Change from baseline in Diabetes Distress Scale (DDS) response | Change from baseline in Diabetes Distress Scale (DDS) response | week 16 | 
| Change from baseline in Diabetes treatment satisfaction questionnaire (DTSQ) response | Change from baseline in Diabetes treatment satisfaction questionnaire (DTSQ) response | week 16 | 
| Number of days with at least one BG test | Number of days with at least one BG test | week 16 | 
| Change from baseline in Body weight | Change from baseline in Body weight | week 16 | 
| Number of Adverse events during study period | Number of Adverse events (related/not related) | week 16 | 
| Number of Serious adverse events during study period | Number of Serious Adverse events (related/not related) | week 16 | 
| Correlation of number of dose adjustment completions to change in HbA1c | Correlation of number of dose adjustment completions to change in HbA1c | week 16 | 
| 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 | For MIDS arm only | week 16 | 
| Number of dose adjustments to first reach avg FBG target range during study period | For MIDS arm only | week 16 | 
| Total insulin degludec dose for subjects who reached avg FBG target at last dose checkup. | For MIDS arm only | week 16 | 
| Frequency of FBG tests during study period | For MIDS arm only | week 16 | 
| Proportion of accepted MIDS recommended insulin degludec doses | For MIDS arm only | week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glooko, Tresiba, Tresiba® U-200 FlexTouch®, Degludec, MIDS, Mobile Insulin Dosing System