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Trial · NCT07884526

AI-CARE: A Novel AI-Driven Mobile Insulin Calculator Integrating Image- Based Carbohydrate Estimation and CGM

NCT07884526, Not applicable, Not yet recruiting, Tan Tock Seng Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. AI-CARE: A Novel AI-Driven Mobile Insulin Calculator Integrating Image- Based Carbohydrate Estimation and CGM. Trials, record NCT07884526. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07884526

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
AI-CARE: A Novel AI-Driven Mobile Insulin Calculator Integrating Image- Based Carbohydrate Estimation and CGM
NCT number
NCT07884526
Status
Not yet recruiting
Phases
Not applicable
Enrollment
48 participants, estimated
Lead sponsor
Tan Tock Seng Hospital
Conditions
Diabetes Mellitus
Interventions
AI-CARE, Usual Care Group
First posted
2026-10-20
Last updated
2026-10-20

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime to achieve target sample sizeFrom enrollment to the end of follow-up at 12 weeksRecruitment feasibility will be evaluated by measuring the time (in weeks) required to achieve the target sample size.
PrimaryEligibility rateFrom enrollment to the end of follow-up at 12 weeksRecruitment feasibility will also be measured by calculating the eligibility rate, which is the proportion of eligible participants among those screened.
PrimaryRecruitment rateFrom enrollment to the end of follow-up at 12 weeksRecruitment feasibility will also be measured by calculating the recruitment rate, which is the proportion of enrolled participants among those eligible.
PrimaryRetention and attrition ratesFrom enrollment to the end of follow-up at 12 weeksRetention and attrition rates will also be calculated, with attrition defined as the proportion of participants who withdraw or are lost to follow-up during the 12-week intervention period.
PrimaryIntervention engagementFrom enrollment to the end of follow-up at 12 weeks
Intervention engagement will be assessed through application usage metrics, including the frequency of daily insulin calculator activation and the proportion of meals supported by AI-CARE. Acceptability will be further inferred from app usage patterns.
PrimaryIntervention usabilityFrom enrollment to the end of follow-up at 12 weeks
Usability will be evaluated using the validated mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients, which will be administered at Week 12. In the MAUQ questionnaire, there are 18 statements, for which participants indicate their level of agreement on a 7-point scale (1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree). To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app. There is also a section for participants' written comments. Acceptability will be further inferred from participant feedback.
SecondaryChanges in glycaemic control (HbA1c)From enrollment to the end of follow-up at 12 weeksChanges in glycaemic control will be assessed using HbA1c (%).
SecondaryContinuous glucose monitoring-derived metricsFrom enrollment to the end of follow-up at 12 weeks
Continuous glucose monitoring-derived metrics include Time in Range (TIR), Time Above Range (TAR) and Time Below Range (TBR). TIR is the percentage of time that blood glucose stays within the normal range. TAR is the percentage of time that blood glucose rises above the target range. TBR is the percentage of time that blood glucose falls below the target range.
SecondaryBody WeightFrom enrollment to the end of follow-up at 12 weeksBody weight will be measured in kilograms and evaluated to explore broader metabolic effects of the intervention.
SecondaryBody Mass Index (BMI)From enrollment to the end of follow-up at 12 weeksWeight (in kilograms) and height (in meters) will be aggregated to report BMI in kg/m\^2) and evaluated to explore broader metabolic effects of the intervention.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
22268422BACKGROUNDPubMed
25883163BACKGROUNDPubMed
26796634BACKGROUNDPubMed
27170498BACKGROUNDPubMed
28533136BACKGROUNDPubMed
41659334BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07884526

GET https://conductscience.org/api/trials/v1/NCT07884526/registered