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Completed

NCT Number: NCT02313363

Patient-Centered Smartphone-Based Diabetes Care

The investigators developed a patient-centered smartphone-based diabetes care system (PSDCS). This study was aimed to test the feasibility of the PSDCS.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetes
  • HbA1c levels ≥ 6.5%

Exclusion criteria

  • severe diabetic complication including severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy, chronic kidney disease stage 4-5, severe diabetic neuropathy, history of diabetic foot, history of angina pectoris, myocardial infarction, and cerebrovascular disease, and peripheral arterial disease
  • type 1 diabetes
  • insulin therapy other than insulin glargine
  • subjects with insulin pump
  • history of drug addiction
  • history of psychotic disorder
  • pregnancy

Treatment and study plan

patient-centered smartphone-based diabetes care system

Device

patient-centered smartphone-based diabetes care system (PSDCS) is composed of 4 modules such as glucose module, diet module, physical activity module, and SNS module. Participants were instructed to use the PSDCS and to measure blood glucose levels with a Bluetooth glucometer, input daily food intake, and wear an activity tracker.

Primary outcomes

  1. change of HbA1c

    Time frame: baseline and the end of 12 week

Secondary outcomes

  1. change of fasting plasma glucose

    Time frame: baseline and after 12 weeks (within 3 days)

  2. change of lipid profile

    Time frame: baseline and after 12 weeks (within 3 days)

  3. change of body weight

    Time frame: baseline and after 12 weeks (within 3 days)

  4. change of the scores of Summary of Diabetes Self-Care Activities (SDSCA)

    Time frame: baseline and after 12 weeks (within 3 days)

Other outcomes

  1. number of events of serious hyperglycemia

    Time frame: 12 weeks

    320 mg/dL or higher by the glucometer readouts

  2. number of events of hypoglycemia

    Time frame: 12 weeks

    less than 70 mg/dL by the glucometer readouts

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Feasibility of a Patient-Centered Smartphone-Based Diabetes Care System: a Pilot Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2014
Registry last updated
Dec 10, 2014

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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