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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000038 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| New York City Health and Hospitals Corporation | OTHER |
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The purpose of this pilot study is to determine whether text message (and phone) communication can be effectively utilized to adjust long-acting insulin, compared to standard practice.
The current practice of insulin titration for diabetics requires multiple in-person clinic visits, during which a patient's long-acting insulin dose is adjusted until the optimal dose to control glycemia is reached. Finding this optimal dose can take weeks in an ideal setting, but often takes much longer in a busy urban clinic such as Bellevue Hospital Center. Relaying titration instructions to patients via phone and text message has the potential to decrease the titration timeline, thus reducing the number of clinic visits and the time it takes patients to reach their target blood glucose levels.
For this pilot project, study staff will recruit patients who are initiating long-acting insulin treatment or initiating the titration of their existing long acting insulin treatment at Bellevue Hospital Center's Adult Primary Care Center. Patients who volunteer to enroll and provide informed consent will be randomized to one of two arms (MITI or current best practice arm) at the time of enrollment and stratified by whether the patient is initiating insulin treatment or initiating the titration of his/her existing insulin dose. The study staff will provide a cell phone (for temporary use) to any patients who are randomized to the MITI arm and don't own a personal cell phone (or whose personal cell phone is not able to receive the Sense Health text messages). Patients will use the cell phone free of cost to participate in the intervention (receive Sense Health text messages, send their fasting blood glucose levels, and speak with the diabetes nurse and study staff.)
Patients in the MITI arm will receive automated text messages 5 weekdays per week, for up to 12 weeks, from Sense Health. These text messages will request the patient's fasting blood glucose level. The patient will reply with his/her fasting blood glucose value, which will be logged in password-protected accounts on www.sensehealth.com. The clinic's diabetes nurses will check each patient's fasting blood glucose level on www.sensehealth.com each weekday and call any patient with fasting blood glucose values < 80 mg/dL and > 400 mg/dL. Each Thursday, patients will receive a phone call from a nurse, who will adjust the patient's insulin dose according to the study titration protocol. Each patient will continue to receive daily text messages and weekly phone calls until the first of three events occur: the patient reaches his/her optimal insulin dose for achieving glycemic control, 12 weeks elapse, or the patient withdraws from the study.
Patients in the current best practice arm (CBP) will attend scheduled clinic appointments during which a provider will review the patient's fasting blood glucose log and titrate the insulin dose according to current best practice.
Patients in both arms will continue receiving routine care, including HbA1c values every 3 months and other routine labs and measures as per standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Insulin Titration Intervention | Experimental | Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. |
|
| Current Best Practice | No Intervention | Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Insulin Titration Intervention | Other | Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Optimal Long-acting Insulin Dose | The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms. | 12 weeks |
| Hemoglobin A1c | Change in hemoglobin A1c |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Text Message Responses | The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent. | 12 weeks |
| Percentage of Successful Phone Calls |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalie Levy, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adult Primary Care Clinic, Bellevue Hospital Center | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14578243 | Background | Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6. doi: 10.2337/diacare.26.11.3080. | |
| 15920040 | Background | Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Insulin Titration Intervention | Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration. |
| FG001 | Current Best Practice | Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Insulin Titration Intervention | Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose | No primary outcome data available for one participant in Current Best Practice arm who discontinued insulin early due to a mild possible allergy. | Posted | Number | percentage of participants | 12 weeks |
|
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We were able to assess serious adverse events for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). No serious adverse events were found.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mobile Insulin Titration Intervention | Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse. Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild hypoglycemia | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Natalie Levy | New York University School of Medicine | 2122638924 | Natalie.Levy@nyumc.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| baseline, 12 weeks (approximately 3 months) |
| Baseline Treatment Satisfaction | The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied. | baseline |
| Treatment Satisfaction After Initiation of Insulin Titration | The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied. | 12 weeks (approximately 3 months) |
| Change in Treatment Satisfaction | The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now. | 12 weeks (approximately 3 months) |
| Incidence of Hypoglycemia | The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms. | 12 weeks |
The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent. |
| 12 weeks |
| Patient Healthcare Utilization | The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits). | 12 weeks |
| Costs - Provider Time Spent on Insulin Titration Visits | Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic. | 12 weeks |
| Costs - Titration Visit Information | The number of insulin titration visits (whether by phone or in the clinic). | 12 weeks |
| Costs - Patient Travel Time | The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits. | 12 weeks |
| Costs - Co-pays | At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital. | baseline |
| Qualitative Patient Satisfaction Interview | The study staff will interview MITI arm patients, using free-response questions, to assess their satisfaction with the intervention. The interviews will take place in person or over the phone at the patient's convenience, after the patient has reached his/her optimal insulin dose. If the patient does not reach optimal insulin dose, the interview will take place at approximately 12 weeks. | After patient reaches optimal insulin dose or at 12 weeks |
| 18355327 | Background | 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. |
| 19515182 | Background | 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. |
| 22524591 | Background | Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23. |
| 21193619 | Background | Walker EA, Shmukler C, Ullman R, Blanco E, Scollan-Koliopoulus M, Cohen HW. Results of a successful telephonic intervention to improve diabetes control in urban adults: a randomized trial. Diabetes Care. 2011 Jan;34(1):2-7. doi: 10.2337/dc10-1005. |
| 26187303 | Derived | Levy N, Moynihan V, Nilo A, Singer K, Bernik LS, Etiebet MA, Fang Y, Cho J, Natarajan S. The Mobile Insulin Titration Intervention (MITI) for Insulin Adjustment in an Urban, Low-Income Population: Randomized Controlled Trial. J Med Internet Res. 2015 Jul 17;17(7):e180. doi: 10.2196/jmir.4716. |
| 25794243 | Derived | Levy N, Moynihan V, Nilo A, Singer K, Bernik LS, Etiebet MA, Fang Y, Cho J, Natarajan S. The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2015 Mar 13;4(1):e31. doi: 10.2196/resprot.4206. |
| Did not initiate insulin treatment |
|
| Phenotypic type 1 diabetes |
|
| Discontinued insulin - possible allergy |
|
| BG001 | Current Best Practice | Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Current Best Practice |
Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions. |
|
|
|
| Secondary | Time to Reach Optimal Long-acting Insulin Dose | The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms. | Participants who reached optimal long-acting insulin dose. | Posted | Median | Inter-Quartile Range | weeks | 12 weeks |
|
|
|
|
| Secondary | Hemoglobin A1c | Change in hemoglobin A1c | All participants with hemoglobin A1c measurements recorded at baseline and 12 weeks. | Posted | Mean | Standard Deviation | mg/dL | baseline, 12 weeks (approximately 3 months) |
|
|
|
|
| Secondary | Baseline Treatment Satisfaction | The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied. | All participants who completed the treatment satisfaction questionnaire at baseline. | Posted | Mean | Standard Deviation | score on satisfaction scale | baseline |
|
|
|
|
| Secondary | Treatment Satisfaction After Initiation of Insulin Titration | The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied. | All participants who completed the treatment satisfaction questionnaire at 12 weeks. | Posted | Mean | Standard Deviation | score on satisfaction scale | 12 weeks (approximately 3 months) |
|
|
|
|
| Secondary | Change in Treatment Satisfaction | The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now. | All participants who completed the treatment satisfaction questionnaire at 12 weeks. | Posted | Mean | Standard Deviation | score on satisfaction scale | 12 weeks (approximately 3 months) |
|
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|
|
| Secondary | Incidence of Hypoglycemia | The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms. | This outcome was analyzed for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). Five participants reported hypoglycemia: 3 in the MITI arm and 2 in the CBP arm. All cases were mild. | Posted | Number | instances of hypoglycemia | 12 weeks |
|
|
|
| Other Pre-specified | Percentage of Text Message Responses | The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent. | Participants who completed the allocated intervention. | Posted | Number | percentage of text messages | 12 weeks | text messages sent to participants | Participants |
|
|
|
| Other Pre-specified | Percentage of Successful Phone Calls | The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent. | Participants who completed the allocated intervention. | Posted | Number | percentage of phone calls | 12 weeks | titration phone calls assigned to nurse | Participants |
|
|
|
| Other Pre-specified | Patient Healthcare Utilization | The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits). | All participants. | Posted | Number | hospital visits | 12 weeks |
|
|
|
| Other Pre-specified | Costs - Provider Time Spent on Insulin Titration Visits | Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic. | Insulin titration visits with a duration recorded. | Posted | Median | Inter-Quartile Range | minutes | 12 weeks | type of insulin titration visit | Participants |
|
|
|
|
| Other Pre-specified | Costs - Titration Visit Information | The number of insulin titration visits (whether by phone or in the clinic). | Participants who completed the allocated intervention (and the participant who discontinued insulin early). | Posted | Median | Inter-Quartile Range | insulin titration visits | 12 weeks |
|
|
|
|
| Other Pre-specified | Costs - Patient Travel Time | The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits. | Posted | Median | Inter-Quartile Range | minutes | 12 weeks |
|
|
|
| Other Pre-specified | Costs - Co-pays | At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital. | Posted | Number | participants | baseline |
|
|
|
| Other Pre-specified | Qualitative Patient Satisfaction Interview | The study staff will interview MITI arm patients, using free-response questions, to assess their satisfaction with the intervention. The interviews will take place in person or over the phone at the patient's convenience, after the patient has reached his/her optimal insulin dose. If the patient does not reach optimal insulin dose, the interview will take place at approximately 12 weeks. | Not Posted | After patient reaches optimal insulin dose or at 12 weeks |
| 0 |
| 28 |
| 3 |
| 28 |
| EG001 | Current Best Practice | Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions. | 0 | 27 | 3 | 27 |
| mild possible allergy to insulin | General disorders | Non-systematic Assessment |
|
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| D006946 | Hyperinsulinism |