NCT01698528

Brief Summary

The purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at Joslin Diabetes Center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

October 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 14, 2017

Completed
Last Updated

October 24, 2018

Status Verified

September 1, 2018

Enrollment Period

3 years

First QC Date

October 1, 2012

Results QC Date

April 20, 2017

Last Update Submit

September 28, 2018

Conditions

Type II Diabetes

Keywords

Diabetesdiabetes technologiestelemedicine

Outcome Measures

Primary Outcomes (1)

  • Glycemic Control as Determined by the Change in Absolute HbA1c Level

    The primary outcome of interest is absolute decrease in A1c by end of 3 months.

    3 months

Secondary Outcomes (4)

  • Number of Participants Reaching Target of HbA1c ≤ 7%

    3 months

  • Change in Average Participation Satisfaction

    3 months

  • Number of Participants With Hypoglycemia

    3 months

  • Time Health Care Providers and Subjects Spend on Managing the Insulin Titration

    3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.

Device: Tablet Computer

Control Group

NO INTERVENTION

The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.

Interventions

Tablet ComputerDEVICE
Also known as: Toshiba tablet computer
Intervention Group

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Has type 2 diabetes, starting on basal insulin therapy
  • Hemoglobin A1c between 9-14%
  • Has Wi-Fi internet connection at home
  • Is willing to monitor blood glucose at least once per day
  • Is willing to inject and self-titrate insulin dose
  • Able to read and communicate in English proficiently

You may not qualify if:

  • Has severe visual impairment impacting visual acuity
  • Has severe hearing impairment impacting communication
  • Has Type 1 diabetes
  • Pregnant or lactating women
  • Alcohol dependency
  • Require multiple daily insulin injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr William Hsu
Organization
Joslin Diabetes Center
william.hsu@joslin.harvard.edu
617-309-5803

Study Officials

  • William Hsu, M.D.

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 3, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 24, 2018

Results First Posted

September 14, 2017

Record last verified: 2018-09

Locations

US(1)