NCT01879579

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

October 12, 2015

Completed
Last Updated

October 12, 2015

Status Verified

September 1, 2015

Enrollment Period

1.7 years

First QC Date

June 13, 2013

Results QC Date

August 11, 2015

Last Update Submit

September 15, 2015

Conditions

Diabetes Mellitus

Keywords

InsulinTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose

    12 weeks

Secondary Outcomes (6)

  • Time to Reach Optimal Long-acting Insulin Dose

    12 weeks

  • Hemoglobin A1c

    baseline, 12 weeks (approximately 3 months)

  • Baseline Treatment Satisfaction

    baseline

  • Treatment Satisfaction After Initiation of Insulin Titration

    12 weeks (approximately 3 months)

  • Change in Treatment Satisfaction

    12 weeks (approximately 3 months)

  • +1 more secondary outcomes

Other Outcomes (8)

  • Percentage of Text Message Responses

    12 weeks

  • Percentage of Successful Phone Calls

    12 weeks

  • Patient Healthcare Utilization

    12 weeks

  • +5 more other outcomes

Study Arms (2)

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.

Other: Mobile Insulin Titration Intervention

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.

Interventions

Mobile Insulin Titration InterventionOTHER

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.

Mobile Insulin Titration Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adult Primary Care Clinic, Bellevue Hospital Center

New York, New York, 10016, United States

Location

Related Publications (8)

  • 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.

    PMID: 14578243BACKGROUND

  • 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.

    PMID: 15920040BACKGROUND

  • 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.

    PMID: 18355327BACKGROUND

  • 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.

    PMID: 19515182BACKGROUND

  • 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.

    PMID: 22524591BACKGROUND

  • 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.

    PMID: 21193619BACKGROUND

  • 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.

    PMID: 26187303DERIVED

  • 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.

    PMID: 25794243DERIVED

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Results Point of Contact

Title
Dr. Natalie Levy
Organization
New York University School of Medicine
Natalie.Levy@nyumc.org
2122638924

Study Officials

  • Natalie Levy, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 18, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

October 12, 2015

Results First Posted

October 12, 2015

Record last verified: 2015-09

Locations

US(1)