Insulin Degludec Titration Using Mobile Insulin Dosing System

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Device: Glooko Mobile Insulin Dosing System(MIDS)

• Registration Number: NCT03091712
• Lead Sponsor: Glooko

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.

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 Timeline

• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Study Start: 2017-05-05
• Primary Completion: 2019-08-08
• Study Completion: 2019-09-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paper Titration Tool and Glooko MIDS	Glooko Mobile Insulin Dosing System(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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Scripps Whittier Diabetes Institute; 🇺🇸 San Diego, California, United States