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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glooko Mobile Insulin Dosing System(MIDS) | Device | Mobile Insulin Dosing System (MIDS) for all long acting insulin degludec titration management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in HbA1c at 16 weeks from baseline for all subjects that adhere to treatment. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c | Change from baseline in HbA1c | Week 12 |
| Proportion of synced BG readings < 54 mg/dL | Proportion of synced BG readings < 54 mg/dL |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Greenfield, MD | Glooko | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Whittier Diabetes Institute | San Diego | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | IDF 2015 Atlas: http://www.diabetesatlas.org/resources/2015-atlas. html | ||
| Background | 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 | ||
| 22695461 | Background | Ali MK, McKeever Bullard K, Imperatore G, Barker L, Gregg EW; Centers for Disease Control and Prevention (CDC). Characteristics associated with poor glycemic control among adults with self-reported diagnosed diabetes--National Health and Nutrition Examination Survey, United States, 2007-2010. MMWR Suppl. 2012 Jun 15;61(2):32-7. | |
| 17504861 |
| Label | URL |
|---|---|
| Pew Research Center(accessed May 18, 2016) | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Prospective, open label, randomized, controlled, parallel intervention study.
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| Week 16 |
| Proportion of synced BG readings < 70 mg/dL | Proportion of synced BG readings < 70 mg/dL | Week 16 |
| Proportion of synced BG readings >250 mg/dL | Proportion of synced BG readings >250 mg/dL | Week 16 |
| Proportion of synced BG readings in target range (80-180mg/dL) | Proportion of synced BG readings in target range (80-180mg/dL) | Week 16 |
| 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 |
| 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 |
| 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 |
| Total insulin degludec dose | Total insulin degludec dose | Week 12 and Week 16 |
| Change from baseline in Hypoglycemia fear survey- II response | Change from baseline in Hypoglycemia fear survey- II response | Week 16 |
| Change from baseline in Diabetes Distress Scale (DDS) response | Change from baseline in Diabetes Distress Scale (DDS) response | week 16 |
| Change from baseline in Diabetes treatment satisfaction questionnaire (DTSQ) response | Change from baseline in Diabetes treatment satisfaction questionnaire (DTSQ) response | week 16 |
| Number of days with at least one BG test | Number of days with at least one BG test | week 16 |
| Change from baseline in Body weight | Change from baseline in Body weight | week 16 |
| Number of Adverse events during study period | Number of Adverse events (related/not related) | week 16 |
| Number of Serious adverse events during study period | Number of Serious Adverse events (related/not related) | week 16 |
| Correlation of number of dose adjustment completions to change in HbA1c | Correlation of number of dose adjustment completions to change in HbA1c | week 16 |
| 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 |
| Number of dose adjustments to first reach avg FBG target range during study period | For MIDS arm only | week 16 |
| Total insulin degludec dose for subjects who reached avg FBG target at last dose checkup. | For MIDS arm only | week 16 |
| Frequency of FBG tests during study period | For MIDS arm only | week 16 |
| Proportion of accepted MIDS recommended insulin degludec doses | For MIDS arm only | week 16 |
| Background |
| 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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| Background | Pew Research Center: http://www.pewinternet.org/2015/10/29/ technology-device-ownership-2015/ (accessed May 18, 2016) |
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| D004700 | Endocrine System Diseases |