NCT06173934

Brief Summary

Establish a cohort study to describe the characteristics of gastric emptying in patients with type 1 diabetes, and adjust the timing of insulin injection during meals to improve blood glucose fluctuations according to the speed of gastric emptying.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

December 6, 2023

Last Update Submit

December 15, 2023

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Characteristics of gastric emptying(the gastric half-emptying time ) in patients with type 1 diabetes.

    Correlation of gastric emptying with disease course, blood glucose fluctuation and complications.

    1, 2, 3 years

Secondary Outcomes (1)

  • The blood glucose

    1, 2, 3 years

Study Arms (2)

Patients with rapid gastric emptying

EXPERIMENTAL

Patients with rapid gastric emptying

Drug: insulin injection 15 minutes before meals

Patients with slow gastric emptying

EXPERIMENTAL

Patients with slow gastric emptying

Drug: Insulin injection 15 minutes after eating

Interventions

insulin injection 15 minutes before mealsDRUG

Adjust insulin injection time to observe blood glucose spectrum

Also known as: insulin regulation
Patients with rapid gastric emptying
Insulin injection 15 minutes after eatingDRUG

Adjust insulin injection time to observe blood glucose spectrum

Also known as: insulin regulation
Patients with slow gastric emptying

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer and sign subject informed consent prior to the trial.
  • Patients with type 1 diabetes, aged less than 70 years, 7%≤HbA1c≤9.0%.
  • There were no acute complications such as diabetic ketoacidosis and diabetic hypertonic syndrome.
  • Subjects were able and willing to undergo 14-day scanning blood glucose monitoring, diet and exercise routine.

You may not qualify if:

  • Patients with severe gastrointestinal symptoms, history of gastrointestinal disease, surgical history, or impaired liver and kidney function.
  • Patients who have used drugs that affect gastrointestinal function or appetite in the last week.
  • History of drug abuse and alcohol dependence within the past 5 years.
  • Systemic hormone therapy was used in the last three months.
  • Patients with poor compliance, irregular diet and exercise.
  • Patients with infection and stress within four weeks.
  • Patients who could not tolerate 14-day scanning blood glucose monitoring.
  • Patients who are pregnant, nursing or intending to become pregnant.
  • Any other obvious condition or comorbidities determined by the investigator: such as serious cardiopulmonary disease, endocrine disease, neurological, neoplastic, other pancreatic disease, history of mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jianhua Ma

    Nanjing Medical University affiliated Nanjing First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Luo

CONTACT

+86 18951670850luoyong132270@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 18, 2023

Study Start

December 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations

CN(1)