Insulin Degludec Titration Using Mobile Insulin Dosing System
NCT ID: NCT03091712
Last Updated: 2020-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2017-05-05
2019-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Glooko Mobile Insulin Dosing System(MIDS)
Mobile Insulin Dosing System (MIDS) for all long acting insulin degludec titration management
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.
No interventions assigned to this group
Interventions
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Glooko Mobile Insulin Dosing System(MIDS)
Mobile Insulin Dosing System (MIDS) for all long acting insulin degludec titration management
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Glooko
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Greenfield, MD
Role: STUDY_DIRECTOR
Glooko
Locations
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Scripps Whittier Diabetes Institute
San Diego, California, United States
Countries
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References
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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
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Donnelly LA, Morris AD, Evans JM; DARTS/MEMO collaboration. Adherence to insulin and its association with glycaemic control in patients with type 2 diabetes. QJM. 2007 Jun;100(6):345-50. doi: 10.1093/qjmed/hcm031. Epub 2007 May 15.
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Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x.
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Balkrishnan R, Rajagopalan R, Camacho FT, Huston SA, Murray FT, Anderson RT. Predictors of medication adherence and associated health care costs in an older population with type 2 diabetes mellitus: a longitudinal cohort study. Clin Ther. 2003 Nov;25(11):2958-71. doi: 10.1016/s0149-2918(03)80347-8.
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Ratanawongsa N, Crosson JC, Schillinger D, Karter AJ, Saha CK, Marrero DG. Getting under the skin of clinical inertia in insulin initiation: the Translating Research Into Action for Diabetes (TRIAD) Insulin Starts Project. Diabetes Educ. 2012 Jan-Feb;38(1):94-100. doi: 10.1177/0145721711432649. Epub 2012 Jan 5.
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Strain WD, Cos X, Hirst M, Vencio S, Mohan V, Voko Z, Yabe D, Bluher M, Paldanius PM. Time to do more: addressing clinical inertia in the management of type 2 diabetes mellitus. Diabetes Res Clin Pract. 2014 Sep;105(3):302-12. doi: 10.1016/j.diabres.2014.05.005. Epub 2014 May 27.
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Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x.
Meneghini L, Koenen C, Weng W, Selam JL. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes--results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007 Nov;9(6):902-13. doi: 10.1111/j.1463-1326.2007.00804.x.
Davies M, Lavalle-Gonzalez F, Storms F, Gomis R; AT.LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab. 2008 May;10(5):387-99. doi: 10.1111/j.1463-1326.2008.00873.x. Epub 2008 Mar 18.
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Walker RJ, Smalls BL, Hernandez-Tejada MA, Campbell JA, Egede LE. Effect of diabetes self-efficacy on glycemic control, medication adherence, self-care behaviors, and quality of life in a predominantly low-income, minority population. Ethn Dis. 2014 Summer;24(3):349-55.
Hou C, Carter B, Hewitt J, Francisa T, Mayor S. Do Mobile Phone Applications Improve Glycemic Control (HbA1c) in the Self-management of Diabetes? A Systematic Review, Meta-analysis, and GRADE of 14 Randomized Trials. Diabetes Care. 2016 Nov;39(11):2089-2095. doi: 10.2337/dc16-0346.
Related Links
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Pew Research Center(accessed May 18, 2016)
Other Identifiers
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GL3
Identifier Type: -
Identifier Source: org_study_id
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