An interventional study of Standard Information Intervention and Gain-Framed Information Intervention in Diabetes Mellitus, Type 2 and Influenza, sponsored by Southeast University, China. Completed at 4 sites in China. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Southeast University, China · Not applicable, Interventional, and Prevention
Among 905 studies in Diabetes Mellitus, Type 2 with a site in China — 201 open to participants now, 226 under way, 45 of them phase 3. Diabetes Mellitus, Type 2 · China.
Among the 905 studies in Diabetes Mellitus, Type 2 with a site in China, this one is the 106th largest by enrollment of the 764 interventional ones that give a count, is one of 62 that started in 2023, is one of 194 with no phase, and was the 896th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 759 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →201 of the 905 studies in Diabetes Mellitus, Type 2 with a site in China are open now.
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 60 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →905 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 142 · Phase 2 90 · Phase 3 213 · Phase 4 155
First in 1998; this study’s year is marked. 62 started in 2023.
Median enrollment 191 across the 764 interventional studies, 575 across the 140 observational. Of the 516 that completed or were terminated, 123 (24%) have results posted.
445 of 905 have an industry lead sponsor. The 10 most frequent:
Southeast University, China is the lead sponsor of 168 studies on the registry; 45 are open to participants now.
Southeast University, China has 2 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
56 of the studies in Diabetes Mellitus, Type 2 with a site in China that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06716216Phase 3BrightGene Bio-Medical Technology Co., Ltd.A Study of BGM0504 in Participants With Type 2 Diabetes | 2026-11-14 |
| NCT06716203Phase 3BrightGene Bio-Medical Technology Co., Ltd.A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise | 2026-11-14 |
| NCT07060456Phase 3Fujian Shengdi Pharmaceutical Co., Ltd.Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin | 2027-02 |
| NCT07082114Phase 3Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus | 2027-02-16 |
| NCT07156500Phase 3Jiangsu Hansoh Pharmaceutical Co., Ltd.A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone | 2027-03-30 |
Among the 905 studies in Diabetes Mellitus, Type 2 with a site in China, from their registry updates:
Influenza can cause serious illness in older adults, particularly those with diabetes. Although influenza vaccination is an important preventive measure, vaccination uptake among older adults in China remains low.
This study aimed to evaluate whether different ways of presenting influenza vaccination information could encourage vaccination among older adults with diabetes in Yangzhou, China.
Adults aged 60 to 75 years with diabetes were assigned to one of four study groups: a control group without intervention text messages, a standard information group, a gain-framed information group emphasizing the benefits of vaccination, and a loss-framed information group emphasizing the potential negative consequences of not being vaccinated.
The primary outcome was influenza vaccination uptake during follow-up. Secondary outcomes included willingness to receive influenza vaccination and vaccine literacy. The study examined whether information-based interventions could improve vaccination-related outcomes compared with the control group.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the control group received no study-specific influenza vaccination information intervention. They completed baseline and follow-up assessments.
Participants assigned to this group received standard, factual information about influenza and influenza vaccination, without emphasizing either the benefits of vaccination or the risks of non-vaccination. The intervention consisted of an educational video followed by a reinforcement reminder card.
Behavioral: Standard Information Intervention
Participants assigned to this group received influenza vaccination information framed to emphasize the potential benefits of vaccination, including protection against influenza and its complications among older adults with diabetes. The intervention consisted of a gain-framed educational video followed by a reinforcement reminder card.
Behavioral: Gain-Framed Information Intervention
Participants assigned to this group received influenza vaccination information framed to emphasize the potential negative consequences of not being vaccinated, including an increased risk of influenza infection and related complications among older adults with diabetes. The intervention consisted of a loss-framed educational video followed by a reinforcement reminder card.
Behavioral: Loss-Framed Information Intervention
This intervention provided standard, factual information about influenza and influenza vaccination without emphasizing the benefits of vaccination or the risks of non-vaccination. The intervention consisted of an approximately 10-minute educational video and a subsequent reinforcement reminder card.
This intervention provided gain-framed information emphasizing the potential benefits of influenza vaccination, including protection against influenza and related complications among older adults with diabetes. The intervention consisted of an approximately 10-minute educational video and a subsequent reinforcement reminder card.
This intervention provided loss-framed information emphasizing the potential negative consequences of not receiving influenza vaccination, including increased susceptibility to influenza and related health complications among older adults with diabetes. The intervention consisted of an approximately 10-minute educational video and a subsequent reinforcement reminder card.
Influenza Vaccination Uptake
The proportion of participants who received an influenza vaccine during the follow-up period, as verified through the electronic immunization information system. Vaccination uptake was calculated as the number of vaccinated participants divided by the number of participants with available vaccination outcome data, multiplied by 100%.
Time frame: From baseline to approximately 6 months (final follow-up)
Change in Vaccine Literacy Score
Vaccine literacy was assessed using a modified Chinese-adapted version of the Health Literacy about Vaccination of Adults in Italian (HLVa-IT) scale. Items were rated on a five-point Likert scale, and the mean item score was calculated, with higher scores indicating greater vaccine literacy. Change was calculated as the post-intervention mean score minus the baseline mean score.
Time frame: Baseline and approximately 6 months (post-intervention)
Change in Influenza Vaccination Intention Score
Influenza vaccination intention was assessed using a single item: 'Will you receive an influenza vaccine in the future?' Responses were rated on a five-point Likert scale from 1 to 5, with higher scores indicating stronger vaccination intention. Change was calculated as the post-intervention score minus the baseline score.
Time frame: Baseline and approximately 6 months (post-intervention)
Plan to share: No — Individual participant data are not planned to be shared at this time. Any future data sharing would require appropriate ethical approval and safeguards to protect participant privacy and confidentiality.
No publications or documents are linked to this record.
Ran from Sep 2023 to primary completion in Apr 2024, 7 months.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 7 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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