臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 23, 2022
Last modified on	Sept. 11, 2025
Trial ID	jRCTs042210167

Scientific Title	An open-label, multicenter, randomized-controlled trial to evaluate the efficacy and safety of a carbohydrate-counting smartphone application with food image recognition system in patients with type 1 diabetes (CARB-LIFE)
Public Title	Efficacy and safety of a carbohydrate-counting smartphone application in type 1 diabetes (CARB-LIFE)

Contact for Scientific Queries	Name	Chujo Daisuke
	Affiliation	Ichikawa Hospital, International University of Health and Welfare
	Address	6-1-14, Kounodai, Ichikawa, Chiba 272-0827, Japan
	Telephone	+81-47-375-1111
	E-mail	chujo-daisuke-rv@ihwg.jp
Contact for Public Queries	Name	Chujo Daisuke
	Affiliation	Ichikawa Hospital, International University of Health and Welfare
	Address	6-1-14, Kounodai, Ichikawa, Chiba 272-0827, Japan
	Telephone	+81-47-375-1111
	E-mail	chujo-daisuke-rv@ihwg.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 23, 2022
Actual date of first enrollment		May. 25, 2022
Target sample size		56
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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
	Exclusion 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
	Age Minimum	6age old over
	Age Maximum	70age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type 1 diabetes
Intervention(s)		Usage of a carbohydrate-counting smartphone application with food image recognition system
Health Condition(s) Keyword		Glucose, insulin treatment, insulin secretion
Intervention(s) Keyword		Smartphone application, carbohydrate-counting
Primary Outcome(s)		Percentages of the time in targeted glucose range (TIR) 24 weeks after intervention
Secondary Outcome(s)		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

Name of Certified Review Board	Clinical Research Review Board, University of Toyama
Address	2630, Sugitani, Toyama, Toyama 930-0194, Japan, Toyama
Telephone	+81-76-415-8857
E-Mail	rinken@adm.u-toyama.ac.jp
Approval Status	Approval
Date of approval	Feb. 03, 2022

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
13	Sept. 11, 2025	(this page)	Changes
12	Sept. 08, 2025	Detail	Changes
11	Aug. 20, 2025	Detail	Changes
10	Aug. 18, 2025	Detail	Changes
9	May. 14, 2025	Detail	Changes
8	April. 04, 2025	Detail	Changes
7	Mar. 06, 2025	Detail	Changes
6	Feb. 17, 2025	Detail	Changes
5	July. 26, 2024	Detail	Changes
4	May. 29, 2024	Detail	Changes
3	Aug. 04, 2023	Detail	Changes
2	July. 07, 2022	Detail	Changes
1	Mar. 23, 2022	Detail

List of change history