Insulin Degludec Titration Using Mobile Insulin Dosing System

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Insulin Degludec Titration Using Mobile Insulin Dosing System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091712
• Other study ID #: GL3
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: September 15, 2019

Study information

• Verified date: March 2020
• Source: Glooko
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 15, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• Glooko Mobile Insulin Dosing System(MIDS)
Mobile Insulin Dosing System (MIDS) for all long acting insulin degludec titration management

Locations

Country	Name	City	State
United States	Scripps Whittier Diabetes Institute	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Glooko

Country where clinical trial is conducted

United States, 

References & Publications (25)

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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

Chandran A, Bonafede MK, Nigam S, Saltiel-Berzin R, Hirsch LJ, Lahue BJ. Adherence to Insulin Pen Therapy Is Associated with Reduction in Healthcare Costs Among Patients with Type 2 Diabetes Mellitus. Am Health Drug Benefits. 2015 May;8(3):148-58. — View Citation

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Hayes RP, Fitzgerald JT, Jacober SJ. Primary care physician beliefs about insulin initiation in patients with type 2 diabetes. Int J Clin Pract. 2008 Jun;62(6):860-8. doi: 10.1111/j.1742-1241.2008.01742.x. Epub 2008 Apr 3. — View Citation

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. Review. — View Citation

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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. — View Citation

Nichols GA, Koo YH, Shah SN. Delay of insulin addition to oral combination therapy despite inadequate glycemic control: delay of insulin therapy. J Gen Intern Med. 2007 Apr;22(4):453-8. — View Citation

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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. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change in HbA1c at 16 weeks from baseline for all subjects that adhere to treatment.	Week 16
Secondary	Change from baseline in HbA1c	Change from baseline in HbA1c	Week 12
Secondary	Proportion of synced BG readings < 54 mg/dL	Proportion of synced BG readings < 54 mg/dL	Week 16
Secondary	Proportion of synced BG readings < 70 mg/dL	Proportion of synced BG readings < 70 mg/dL	Week 16
Secondary	Proportion of synced BG readings >250 mg/dL	Proportion of synced BG readings >250 mg/dL	Week 16
Secondary	Proportion of synced BG readings in target range (80-180mg/dL)	Proportion of synced BG readings in target range (80-180mg/dL)	Week 16
Secondary	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
Secondary	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
Secondary	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
Secondary	Total insulin degludec dose	Total insulin degludec dose	Week 12 and Week 16
Secondary	Change from baseline in Hypoglycemia fear survey- II response	Change from baseline in Hypoglycemia fear survey- II response	Week 16
Secondary	Change from baseline in Diabetes Distress Scale (DDS) response	Change from baseline in Diabetes Distress Scale (DDS) response	week 16
Secondary	Change from baseline in Diabetes treatment satisfaction questionnaire (DTSQ) response	Change from baseline in Diabetes treatment satisfaction questionnaire (DTSQ) response	week 16
Secondary	Number of days with at least one BG test	Number of days with at least one BG test	week 16
Secondary	Change from baseline in Body weight	Change from baseline in Body weight	week 16
Secondary	Number of Adverse events during study period	Number of Adverse events (related/not related)	week 16
Secondary	Number of Serious adverse events during study period	Number of Serious Adverse events (related/not related)	week 16
Secondary	Correlation of number of dose adjustment completions to change in HbA1c	Correlation of number of dose adjustment completions to change in HbA1c	week 16
Secondary	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
Secondary	Number of dose adjustments to first reach avg FBG target range during study period	For MIDS arm only	week 16
Secondary	Total insulin degludec dose for subjects who reached avg FBG target at last dose checkup.	For MIDS arm only	week 16
Secondary	Frequency of FBG tests during study period	For MIDS arm only	week 16
Secondary	Proportion of accepted MIDS recommended insulin degludec doses	For MIDS arm only	week 16

External Links

•   Pew Research Center(accessed May 18, 2016)