Influence of Injection Technique of Premixed Insulin on G... | NCT03513055

Studies
Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus

NCT03513055

Sponsor

Nanjing First Hospital, Nanjing Medical University

Status

Unknown status

Last Update Posted

May 11, 2018Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Type2 Diabetes Mellitus

Interventions

nurse inject premixed insulin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2018Estimated

Primary Completion Date

Sep 30, 2018Estimated

Completion Date

Sep 30, 2018Estimated

First Submitted Date

Apr 17, 2018

First Submission Date that Met QC Criteria

Apr 27, 2018

First Posted Date

May 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2018

Last Update Posted Date

May 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare patients and nurses using insulin pen injector to inject premixed insulin respectively, using continuous glucose monitoring system to evaluate the glucose excursion in the two sets, study the relationship between glucose excursion and inject technique in type 2 diabetes mellitus.

Detailed Description

A total of 60 patients with type 2 diabetes who used premixed insulin will enrolled in this study.Measure their blood pressure，height and weight, BMI, liver and kidney function, blood lipids, glycosylated hemoglobin, fasting glucose, 2 hour postprandial glucose，fasting C peptide, 2 hour postprandial C peptide, fasting glucagon, 2 hour postprandial glucagon,fasting serum insulin，2 hour postprandial serum insulin，urinary albumin and insulin antibodies.The first and second days，the patients inject premixed insulin themselves，the specialist nurse graded the patient's injection technique score.The third and the fourth days the nurse change a new insulin with the same types maintain the same injection dosage.The patient need perform continuous glucose monitoring system(CGMS) for 96-hours.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
inject premixed insulin	Experimental	patients inject premixed insulin themselves then nurse inject premixed insulin	Other: nurse inject premixed insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nurse inject premixed insulin	Other	nurse inject premixed insulin，coaching in the injection technique	inject premixed insulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint was the relationship between MAGE and injection score	the relationship between the 24-h mean amplitude of glycemic excursions (MAGE) and injection score	6 DAYS
the relationship between HbA1C and injection score	the relationship between HbA1C and injection score	6 DAYS
the relationship between SDBG and injection score	the relationship between SDBG and injection score	6 DAYS

Secondary Outcomes

Measure	Description	Time Frame
the relation between insulin antibodies and glucose excursions	the 24-h mean amplitude of glycemic excursions (MAGE)	6 DAYS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 2 diabetes patients
aged 20-80 years
had been on premixed insulin and used an insulin pen for at least 3 months
fasting glucose between 6.1-16 mmolL, postprandial(or random) glucose below 22.2mmol/L.
No acute complications such as diabetic ketoacidosis, diabetic hypertosmolar syndrome.
Subjects were able and willing to ues CGMS and eat regularly.
Patients who were able to inject insulin themselves or actual injections can be accompanied.

Exclusion Criteria:

Insulin allergy.
There has been a history of drug abuse and alcohol dependence in the past five years, or systemic hormone therapy within 3 months.
Patients with poor compliance and irregular eating and exercise.
Infection or stress within four weeks.
Patients unable to tolerate CGMS.
patients with pregnancy, breast-feeding, planning to have a baby
patients with coagulopathy, serious complication,such as cardiovascular disease, end stage renal disease; and patients with severe retinopathy or other eye problems that impair their visual function, or cognitive dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
MA JIANHUA, PHD	Contact	+8618951670116		majianhua196503@126.com

Name	Affiliation	Role
YUAN LU, master	Nanjing Medical University	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30341664	Derived	Yuan L, Li F, Jing T, Ding B, Luo Y, Sun R, Wang X, Diao H, Su X, Ye L, Ma J. Insulin Injection Technique is Associated with Glycemic Variability in Patients with Type 2 Diabetes. Diabetes Ther. 2018 Dec;9(6):2347-2356. doi: 10.1007/s13300-018-0522-1. Epub 2018 Oct 19.