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Completed

NCT Number: NCT01648244

The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes

The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

About this study

The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g. A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses. The software makes a recommendation about what medication changes are appropriate with potential alternates. Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
  • Absence of orders for deployment or permanent change of station
  • Willingness to recruit up to 19 patients prior to randomization
  • Willingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.

Exclusion criteria

  • Specialist physicians
  • Orders for deployment or permanent change of station
  • Unwillingness to recruit up to 19 patients prior to randomization
  • No prior experience with management of type 2 diabetes in adults
  • Unwillingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.

Treatment and study plan

Computer-Assisted Decision Support

Other

The CADS software makes a recommendation about what medication changes are appropriate with potential alternates. CADS providers will either "accept" or "reject" the recommendation by the software.Providers with their patients are block randomized into CADS or "Usual Care" for 1 year. Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month. They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit. Those getting "usual care" will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year.

Primary outcomes

  1. Change in A1c

    Time frame: baseline, 12, 24, 36, and 48 months

    Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care".

Secondary outcomes

  1. Major events

    Time frame: ongoing

    The number of major ("severe") hypoglycemic events whether subjective (undocumented) or objective (SMBG or other confirmation, need for intervention, seizure, coma), and emergency room visits for DM-related causes.

  2. Other DM-related events

    Time frame: ongoing

    Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.

  3. Glucose measures

    Time frame: baseline, 12, 24, 36, 48 months

    Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions

  4. Blood pressure

    Time frame: baseline, 12, 24, 36, and 48 months

    Clinically significant or statistically detectable changes in BP

  5. Lipids

    Time frame: baseline, 12, 24, 36, and 48 months

    Clinically significant or statistically detectable changes in lipid profile.

  6. Patient satisfaction with treatment

    Time frame: basline and 48 months

    Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.

  7. Quality of life

    Time frame: baseline and 48 months

    Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.

  8. Degree of Acceptance

    Time frame: baseline and 48 months

    The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.

  9. Acceptance of uploading data

    Time frame: baseline, 12, 24, 36, and 48 months

    The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire.

  10. Demographic variables

    Time frame: baseline and 48 months

    The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

Fed

Registry information

Official study title

The Use of a Computer Assisted Diabetes Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes Who Are Treated by Primary Care Providers

Acronym: CADS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 24, 2012
Registry last updated
Nov 25, 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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