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Completed

NCT Number: NCT01879579

Mobile Insulin Titration Intervention

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adult Primary Care Clinic, Bellevue Hospital Center

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

  2. Hemoglobin A1c

    Time frame: baseline, 12 weeks (approximately 3 months)

    Change in hemoglobin A1c

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. Percentage of Text Message Responses

    Time frame: 12 weeks

    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.

  2. Percentage of Successful Phone Calls

    Time frame: 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.

  3. Patient Healthcare Utilization

    Time frame: 12 weeks

    The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).

  4. Costs - Provider Time Spent on Insulin Titration Visits

    Time frame: 12 weeks

    Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.

  5. Costs - Titration Visit Information

    Time frame: 12 weeks

    The number of insulin titration visits (whether by phone or in the clinic).

  6. Costs - Patient Travel Time

    Time frame: 12 weeks

    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.

  7. Costs - Co-pays

    Time frame: baseline

    At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.

  8. Qualitative Patient Satisfaction Interview

    Time frame: After patient reaches optimal insulin dose or at 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • New York City Health and Hospitals Corporation

Registry information

Official study title

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

Acronym: MITI

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 18, 2013
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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