Registered outcomes16

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

1 to 16 of 16

List	Outcome	Time frame	Description
Primary	Time to achieve target sample size	From enrollment to the end of follow-up at 12 weeks	Recruitment feasibility will be evaluated by measuring the time (in weeks) required to achieve the target sample size.
Primary	Eligibility rate	From enrollment to the end of follow-up at 12 weeks	Recruitment feasibility will also be measured by calculating the eligibility rate, which is the proportion of eligible participants among those screened.
Primary	Recruitment rate	From enrollment to the end of follow-up at 12 weeks	Recruitment feasibility will also be measured by calculating the recruitment rate, which is the proportion of enrolled participants among those eligible.
Primary	Retention and attrition rates	From enrollment to the end of follow-up at 12 weeks	Retention 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.
Primary	Intervention engagement	From 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.
Primary	Intervention usability	From 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.
Secondary	Changes in glycaemic control (HbA1c)	From enrollment to the end of follow-up at 12 weeks	Changes in glycaemic control will be assessed using HbA1c (%).
Secondary	Continuous glucose monitoring-derived metrics	From 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.
Secondary	Body Weight	From enrollment to the end of follow-up at 12 weeks	Body weight will be measured in kilograms and evaluated to explore broader metabolic effects of the intervention.
Secondary	Body Mass Index (BMI)	From enrollment to the end of follow-up at 12 weeks	Weight (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.
Secondary	Blood Pressure	From enrollment to the end of follow-up at 12 weeks	Blood pressure will be reported in mmHg and evaluated to explore broader metabolic effects of the intervention.
Secondary	Low-Density Lipoprotein Cholesterol	From enrollment to the end of follow-up at 12 weeks	Low Density Lipoprotein (LDL) reported in mmol/L will also be evaluated to explore broader metabolic effects of the intervention.
Secondary	Treatment satisfaction	From enrollment to the end of follow-up at 12 weeks	Patient-reported outcomes will assess changes in diabetes treatment satisfaction as measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The 8 questions in the DTSQ are concerned with the treatment for participants' diabetes (including insulin, tablets and/or diet) and their experience over the past few weeks. The DTSQ (status) questionnaire will be administered at baseline, with each question answered on a 7-point scale (0: very dissatisfied; 6: very satisfied). The maximum score is 48, minimum score is 0. The DTSQ (change) questionnaire will be administered at week 12, with the 7-point scale indicating instead the extent to which participants have experienced changes in the 8 questions (-3: much less satisfied now; 3: much more satisfied now). The maximum score is 24, minimum score is -24.
Secondary	Quality of Life	From enrollment to the end of follow-up at 12 weeks	Changes in quality of life will be assessed using the Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire. The ADDQoL consists of two overview items; one measures generic overall QoL and a further 19 items are concerned with the impact of diabetes on specific aspects of life. The scales range from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Lower scores reflect poorer QoL. Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains.
Secondary	Distress	From enrollment to the end of follow-up at 12 weeks	Changes in diabetes-related distress will be measured using the Diabetes Distress Scale (DDS17). The DDS17 lists 17 potential problem areas that people with diabetes may experience within the past month. Participants indicate on a 6-point scale the extent to which each of the 17 items has caused distress to them (1: not a problem, 6: a very serious problem). This yields a total diabetes distress score pls 4 subscale scores, addressing different kinds of distress; Emotional burden, physician distress, regimen distress and interpersonal distress. To score, sum up the participant's responses and divide by the number of items in that scale. Current research suggests that a mean item score 2.0 - 2.9 should be considered 'moderate distress,' and a mean item score \> 3.0 should be considered 'high distress.'
Other	Intervention Safety	From enrollment to the end of follow-up at 12 weeks	Safety will be monitored throughout the study, with adverse events including severe hypoglycaemia (requiring third-party assistance), diabetic ketoacidosis, and clinically significant hypoglycaemia identified through continuous glucose monitoring (CGM) data review. Any serious or potentially intervention-related adverse event will prompt immediate clinical review and, if necessary, consideration of protocol modification

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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