Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Insulin Degludec Titration Using Mobile Insulin Dosing System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091712
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Glooko

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Device: Glooko Mobile Insulin Dosing System(MIDS) Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, open label, randomized, controlled, parallel intervention study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insulin Degludec Titration Using Mobile Insulin Dosing System
Actual Study Start Date : May 5, 2017
Actual Primary Completion Date : August 8, 2019
Actual Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Paper Titration Tool and Glooko MIDS

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)
Mobile Insulin Dosing System (MIDS) for all long acting insulin degludec titration management
No Intervention: Paper Titration tool

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Week 16 ]
    Change in HbA1c at 16 weeks from baseline for all subjects that adhere to treatment.


Secondary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: Week 12 ]
    Change from baseline in HbA1c

  2. Proportion of synced BG readings < 54 mg/dL [ Time Frame: Week 16 ]
    Proportion of synced BG readings < 54 mg/dL

  3. Proportion of synced BG readings < 70 mg/dL [ Time Frame: Week 16 ]
    Proportion of synced BG readings < 70 mg/dL

  4. Proportion of synced BG readings >250 mg/dL [ Time Frame: Week 16 ]
    Proportion of synced BG readings >250 mg/dL

  5. Proportion of synced BG readings in target range (80-180mg/dL) [ Time Frame: Week 16 ]
    Proportion of synced BG readings in target range (80-180mg/dL)

  6. Change in avg BG between first month and last month of study period [ Time Frame: Baseline and Week 16 ]
    Change in avg BG between first month and last month of study period

  7. Number of visits to Health Care Professional (HCP) outside of the study visits during study period [ Time Frame: Week 16 ]
    Number of visits to Health Care Professional (HCP) outside of the study visits during study period

  8. Number of telephone calls to HCP for insulin titration during study period [ Time Frame: Week 16 ]
    Number of telephone calls to HCP for insulin titration during study period

  9. Total insulin degludec dose [ Time Frame: Week 12 and Week 16 ]
    Total insulin degludec dose

  10. Change from baseline in Hypoglycemia fear survey- II response [ Time Frame: Week 16 ]
    Change from baseline in Hypoglycemia fear survey- II response

  11. Change from baseline in Diabetes Distress Scale (DDS) response [ Time Frame: week 16 ]
    Change from baseline in Diabetes Distress Scale (DDS) response

  12. Change from baseline in Diabetes treatment satisfaction questionnaire (DTSQ) response [ Time Frame: week 16 ]
    Change from baseline in Diabetes treatment satisfaction questionnaire (DTSQ) response

  13. Number of days with at least one BG test [ Time Frame: week 16 ]
    Number of days with at least one BG test

  14. Change from baseline in Body weight [ Time Frame: week 16 ]
    Change from baseline in Body weight

  15. Number of Adverse events during study period [ Time Frame: week 16 ]
    Number of Adverse events (related/not related)

  16. Number of Serious adverse events during study period [ Time Frame: week 16 ]
    Number of Serious Adverse events (related/not related)

  17. Correlation of number of dose adjustment completions to change in HbA1c [ Time Frame: week 16 ]
    Correlation of number of dose adjustment completions to change in HbA1c

  18. 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 [ Time Frame: week 16 ]
    For MIDS arm only

  19. Number of dose adjustments to first reach avg FBG target range during study period [ Time Frame: week 16 ]
    For MIDS arm only

  20. Total insulin degludec dose for subjects who reached avg FBG target at last dose checkup. [ Time Frame: week 16 ]
    For MIDS arm only

  21. Frequency of FBG tests during study period [ Time Frame: week 16 ]
    For MIDS arm only

  22. Proportion of accepted MIDS recommended insulin degludec doses [ Time Frame: week 16 ]
    For MIDS arm only


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091712


Locations
Layout table for location information
United States, California
Scripps Whittier Diabetes Institute
San Diego, California, United States, 92037
Sponsors and Collaborators
Glooko
Investigators
Layout table for investigator information
Study Director: Michael Greenfield, MD Glooko
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:
IDF 2015 Atlas: http://www.diabetesatlas.org/resources/2015-atlas. html
Centers for Disease Control and Prevention (CDC), Diabetes Public Health Resource. Number (in Millions) of Adults with Diabetes by Diabetes Medication Status, United States, 1997-2011: http://www. cdc.gov/diabetes/statistics/meduse/fig1.htm
Pew Research Center: http://www.pewinternet.org/2015/10/29/ technology-device-ownership-2015/ (accessed May 18, 2016)

Layout table for additonal information
Responsible Party: Glooko
ClinicalTrials.gov Identifier: NCT03091712    
Other Study ID Numbers: GL3
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Glooko:
Degludec
MIDS
Mobile Insulin Dosing System
 Glooko
Tresiba
Tresiba® U-200 FlexTouch®
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs