UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046400 |
|---|---|
| Receipt number | R000052944 |
| Scientific Title | A Clinical Trial to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Patients with Prediabetes |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2023/12/27 10:42:56 |
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Basic information
Public title
A Clinical Trial to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Patients with Prediabetes
Acronym
A Clinical Trial to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Patients with Prediabetes
Scientific Title
A Clinical Trial to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Patients with Prediabetes
Scientific Title:Acronym
A Clinical Trial to Validate the Efficacy of Monitoring Blood Glucose, Diet, and Physical Activity in Patients with Prediabetes
Region
| Japan |
Condition
Condition
Prediabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A randomized, parallel-group, controlled clinical trial will be conducted to determine whether voluntary lifestyle modification through dietary and physical activity monitoring using flash glucose monitoring (FGM) and Internet of Things (IoT) terminals can reduce glycemic variability and prevent the onset of diabetes in subjects with prediabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood glucose levels above 70 and below 140 in time before and after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Monitoring of diet and physical activity and recording of FGM data using a smartphone application. Patients can check the relationship between blood glucose, physical activity, and diet data as needed, while obtaining general information on lifestyle improvement through the smartphone application.
Interventions/Control_2
No treatment follow-up
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. pre-diabetic patients (those with a recent HbA1c of 5.6-6.4% or fasting blood glucose of 110-125 mg/dl at a medical checkup conducted after April 2020)
2. Those who can use the smartphone application "Synk Health" (H2 Inc.)
3. Those who already have a physical activity meter (including smartphone application) that is linked to the "Think Health" smartphone application.
4. age between 20 and 80 years old at the time of consent
5. Those who have a BMI of at least 23 kg/m2 or less than 40 kg/m2.
6. Those who have given written consent to participate in the study after the study content has been explained using an explanatory document.
Key exclusion criteria
1. those under treatment for diabetes mellitus
2. those undergoing cancer treatment
3. those taking adrenal corticosteroids
4. other persons deemed inappropriate by the physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | KITAZAWA |
Organization
Niigata University
Division name
Graduate School of Medical and Dental Sciences Department of Hematology, Endocrinology and Metabolism
Zip code
9518510
Address
754 Asahimachi-dori 1-bancho, Chuo-ku, Niigata City
TEL
025-368-9026
m-kitazawa@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | KITAZAWA |
Organization
Niigata University
Division name
Graduate School of Medical and Dental Sciences Department of Hematology, Endocrinology and Metabolis
Zip code
9518510
Address
754 Asahimachi-dori 1-bancho, Chuo-ku, Niigata City
TEL
025-368-9026
Homepage URL
m-kitazawa@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Sompo Himawari Life Insurance Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Ethics Review Board.
Address
757 Asahimachi-dori 1-bancho, Chuo-ku, Niigata City
Tel
025-227-2005
ethics@adm.niigata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
https://academic-oup-com.translate.goog/jcem/advance-article/doi/10.1210/clinem/dgad639/7335884?_x_t
Publication of results
Published
Result
URL related to results and publications
https://academic-oup-com.translate.goog/jcem/advance-article/doi/10.1210/clinem/dgad639/7335884?_x_t
Number of participants that the trial has enrolled
179
Results
TIR for blood glucose 70-140 mg/dL improved more in the App group than in the C group (-2.6 min/day vs +31.5 min/day, p=0.03). BMI (-0.26 vs. -0.59, p=0.02) reduced in the App compared to the C, and the rate of weight loss of 2 kg or more was reduced in the App compared to the C.
Results date posted
| 2023 | Year | 12 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 168 patients (age 48.1 years, BMI 26.6 kg/m2, 80.4% male), 82 were assigned to the App group and 86 to the C group.
Participant flow
Of the 236 people who expressed willingness to participate, written informed consent was obtained from 179. Excluded were 57 individuals who did not meet the eligibility criteria. Eighty-eight persons were assigned to the Control group and 91 to the Intervention group. The FAS analysis was performed on 168 participants with 82 in the Intervention group and 86 in the Control group, excluding 11 patients who did not undergo an examination or intervention after allocation (6 participants, Control group; 5 participants, Intervention group).
Of the remaining participants, 153 and 121 had blood glucose fluctuation data before and after the study period, respectively. As a result, the primary endpoint was analyzed in 116 patients who had blood glucose fluctuation data both before and after the study period. Secondary endpoints derived from evaluating changes before and after the intervention were determined. One Control group participant was later deemed not to meet the inclusion criteria and was excluded from the PPS analysis, resulting in a PPS analysis of 167 participants. Safety analysis included 168 participants, the same as for the FAS.
Adverse events
Hypoglycemia with blood glucose values <70 mg/dl was recorded for 38.6 minutes/day (2.68%) in the Control group and 35.3 minutes/day (2.45%) in the Intervention group in the two weeks before the intervention and for 53.9 minutes/day (3.74%) in the Control group and 31.1 minutes/day (2.16%) in the Intervention group after the end of the 12-week intervention.
No severe hypoglycemia occurred that required medical care. Before the intervention, severe hypoglycemia with blood glucose values <54 mg/dl took place for 8.2 minutes/day (0.57%) in the Control group and 5.8 minutes/day (0.40%) in the Intervention group. After the intervention, this condition occurred for 8.9 minutes/day (0.62%) in the Control group and 3.6 minutes/day (0.24%) in the Intervention group.
Eight adverse events in 5 participants associated with FGM puncture occurred in the Control group (4 pain, 2 bleeding, 2 itching) and 13 events in 11 participants in the Intervention group (9 pain, 2 bleeding, 2 itching), with no severe adverse events leading to discontinuation of the study.
Outcome measures
The primary endpoint was a comparison of the change between the two groups in blood glucose 70-140 mg/dL time before and after the study period, and secondary endpoints included other glycemic variability indices, body weight, dietary intake measured with a questionnaire, and change in physical activity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 17 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052944
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