Mobile Insulin Titration Intervention

Overview

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.

Full Title of Study: “The Mobile Insulin Titration Intervention (MITI) Study: Innovative Chronic Disease Management of Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2015

Detailed Description

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.

Interventions

  • Other: 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • No Intervention: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose
    • Time Frame: 12 weeks

Secondary Measures

  • Time to Reach Optimal Long-acting Insulin Dose
    • Time Frame: 12 weeks
    • The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.
  • Hemoglobin A1c
    • Time Frame: baseline, 12 weeks (approximately 3 months)
    • Change in hemoglobin A1c
  • Baseline Treatment Satisfaction
    • Time Frame: baseline
    • 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.
  • Treatment Satisfaction After Initiation of Insulin Titration
    • Time Frame: 12 weeks (approximately 3 months)
    • 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.
  • Change in Treatment Satisfaction
    • Time Frame: 12 weeks (approximately 3 months)
    • 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.
  • Incidence of Hypoglycemia
    • Time Frame: 12 weeks
    • The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.

Participating in This Clinical Trial

Inclusion Criteria

  • Initiating long-acting insulin treatment or initiating the titration of long-acting insulin treatment – Speaks English or Spanish – Hemoglobin A1c > or = 8% – Able and willing to inject insulin – Able and willing to provide informed consent Exclusion Criteria:

  • Short-acting insulin treatment – Systemic glucocorticoids – Sustained elevated serum creatinine > or = 1.5 mg/dL for men and > or = 1.4 mg/dL for women – Hypoglycemia unawareness – Type 1 diabetes

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NYU Langone Health
  • Collaborator
    • New York City Health and Hospitals Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Natalie Levy, Assistant Professor of Medicine – NYU Langone Health
  • Overall Official(s)
    • Natalie Levy, MD, Principal Investigator, NYU Langone Health

References

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.

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.

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.

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.