Insulin Degludec Titration Using Mobile Insulin Dosing System

NCT03091712 | Completed FDA Device

• 1 other identifier: GL3
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Degludec; MIDS; Mobile Insulin Dosing System; Glooko; Tresiba; Tresiba® U-200 FlexTouch®

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c at 16 weeks from baseline for all subjects that adhere to treatment.

  Week 16

Secondary Outcomes (22)

• Change from baseline in HbA1c

  Week 12

• Proportion of synced BG readings < 54 mg/dL

  Week 16

• Proportion of synced BG readings < 70 mg/dL

  Week 16

• Proportion of synced BG readings >250 mg/dL

  Week 16

• Proportion of synced BG readings in target range (80-180mg/dL)

  Week 16

Study Arms (2)

Paper Titration Tool and Glooko MIDS

EXPERIMENTAL

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)

Paper Titration tool

NO INTERVENTION

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.

Interventions

Glooko Mobile Insulin Dosing System(MIDS) DEVICE

Mobile Insulin Dosing System (MIDS) for all long acting insulin degludec titration management

Paper Titration Tool and Glooko MIDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Glooko: lead

Study Sites (1)

Scripps Whittier Diabetes Institute

San Diego, California, 92037, United States

Location

Related Publications (25)

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Related Links

• Pew Research Center(accessed May 18, 2016)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael Greenfield, MD

  Glooko

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open label, randomized, controlled, parallel intervention study.

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: May 5, 2017
• Primary Completion: August 8, 2019
• Study Completion: September 15, 2019
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)