The Effect of Gastric Emptying on Blood Glucose Profile of Type 1 Diabetes Mellitus and Its Therapeutic Strategies

Last updated: December 15, 2023
Sponsor: Nanjing First Hospital, Nanjing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes Prevention

Diabetic Neuropathy

Treatment

Insulin injection 15 minutes after eating

insulin injection 15 minutes before meals

Clinical Study ID

NCT06173934
KY20230915-11
  • Ages < 70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Volunteer and sign subject informed consent prior to the trial. 2.Patients with type 1 diabetes, aged less than 70 years, 7%≤HbA1c≤9.0%. 3.There were no acute complications such as diabetic ketoacidosis and diabetichypertonic syndrome. 4.Subjects were able and willing to undergo 14-day scanning blood glucose monitoring,diet and exercise routine.

Exclusion

Exclusion Criteria:

  • 1.Patients with severe gastrointestinal symptoms, history of gastrointestinal disease,surgical history, or impaired liver and kidney function. 2.Patients who have used drugs that affect gastrointestinal function or appetite inthe last week. 3.History of drug abuse and alcohol dependence within the past 5 years. 4.Systemic hormone therapy was used in the last three months. 5.Patients with poor compliance, irregular diet and exercise. 6.Patients with infection and stress within four weeks. 7.Patients who could not tolerate 14-day scanning blood glucose monitoring. 8.Patients who are pregnant, nursing or intending to become pregnant. 9.Any other obvious condition or comorbidities determined by the investigator: such asserious cardiopulmonary disease, endocrine disease, neurological, neoplastic, otherpancreatic disease, history of mental illness.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Insulin injection 15 minutes after eating
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
December 31, 2025

Study Description

  1. T1DM that met the inclusion criteria was tested with baseline blood routine, biochemical and complication screening, and FGM monitoring for 14 days (patient blindness) on the basis of the original regimen (insulin pump or basic insulin combined with fast-acting insulin before three meals); A stable diet should be maintained before and during the study.

  2. T1DM that met the inclusion criteria was tested with baseline blood routine, biochemical and complication screening, and FGM monitoring for 14 days (patient blindness) on the basis of the original regimen (insulin pump or basic insulin combined with fast-acting insulin before three meals); A stable diet should be maintained before and during the study.

  3. On the 7th day of FGM monitoring, 13C-GEBT examination was performed on an empty stomach;

  4. Starting from day 8, patients were divided into groups according to the comparison of gastric emptying T50 with pre-experimental healthy people. Group A, patients with rapid gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes before meals; Group B, patients with slow gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes after eating.

  5. FGM monitoring was completed on the 14th day and the study was concluded. 2. On the 7th day of FGM monitoring, 13C-GEBT examination was performed on an empty stomach;

  6. Starting from day 8, patients were divided into groups according to the comparison of gastric emptying T50 with pre-experimental healthy people. Group A, patients with rapid gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes before meals; Group B, patients with slow gastric emptying, adjusted the time of fast-acting insulin injection to 15 minutes after eating.

  7. FGM monitoring was completed on the 14th day and the study was concluded.

Connect with a study center

  • Nanjing First Hospital, Nanjing Medical University

    Nanjing, Jiangsu
    China

    Active - Recruiting

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