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Completed

NCT Number: NCT01698528

Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration

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.

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Key information

Conditions

Type II Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion:

  • 18 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

Exclusion:

  • 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

Treatment and study plan

Tablet Computer

Device

Other names: Toshiba tablet computer

Primary outcomes

  1. Glycemic Control as Determined by the Change in Absolute HbA1c Level

    Time frame: 3 months

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

Secondary outcomes

  1. Number of Participants Reaching Target of HbA1c ≤ 7%

    Time frame: 3 months

    Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.

  2. Change in Average Participation Satisfaction

    Time frame: 3 months

    The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.

  3. Number of Participants With Hypoglycemia

    Time frame: 3 months

    Number of participants had hypoglycemia during the trial period

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

    Time frame: 3 months

    time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Massachusetts Institute of Technology

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 3, 2012
Registry last updated
Oct 24, 2018

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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