Efficacy and safety of a carbohydrate-counting smartphone application in type 1 diabetes

JRCT ID: jRCTs042210167

Registered date:23/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 1 diabetes
• Date of first enrollment: 25/05/2022
• Target sample size: 56
• Study type: Interventional
• Intervention(s): Usage of a carbohydrate-counting smartphone application with food image recognition system

Outcome(s)

• Primary Outcome: Percentages of the time in targeted glucose range (TIR) 24 weeks after intervention

Secondary Outcome

1. Percentages of the time in targeted glucose range (TIR) 12 weeks after intervention
2. Percentages of the time above targeted glucose range (TAR) 12 and 24 weeks after intervention
3. Percentages of the time below targeted glucose range (TBR) 12 and 24 weeks after intervention
4. Values of HbAc and glycated albumin 12 and 24 weeks after intervention
5. Total daily doses of insulin administration 12 and 24 weeks after intervention
6. Body weight and body mass index (BMI) 12 and 24 weeks after intervention
7. Changes in DTR-QOL scores between before and 24 weeks after intervention

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

1. Patients with type 1 diabetes (acute onset, slowly progressive, and fulminant type 1 diabetes)
2. Patients who have a smartphone (iPhone: iOS12 or later)
3. HbA1c < 10.0%
4. Fasting C-peptide <0.6 ng/ml
5. Patients who recieved caobohydrate-counting instruction at least once

Exclude criteria

1. Patients who are participating other clinical trials using glucose-monitoting devices
2. Patients who are not able to keep appointments to come to their hospitals
3. Patients who have any addictions (dependences) or psychotic disorders

Related Information

• Primary Sponsor: Chujo Daisuke