Type2 Diabetes MellitusNCT03513055
Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus
A study testing nurse inject premixed insulin in people with Type2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- nurse inject premixed insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 7 May 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus Using CGMS
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.
Read the 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.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- nurse inject premixed insulin
- Keywords
- glucose excursions, insulin technique, insulin antibodies, premixed insulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse inject premixed insulinOther
nurse inject premixed insulin，coaching in the injection technique
| Study group | Role | What they receive |
|---|---|---|
| inject premixed insulin | Experimental | patients inject premixed insulin themselves then nurse inject premixed insulin Receives: Other: nurse inject premixed insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 DAYS
the relationship between HbA1C and injection score
the relationship between HbA1C and injection score
Measured: 6 DAYS
the relationship between SDBG and injection score
the relationship between SDBG and injection score
Measured: 6 DAYS
Secondary outcomes (1)
the relation between insulin antibodies and glucose excursions
the 24-h mean amplitude of glycemic excursions (MAGE)
Measured: 6 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start7 May 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YUAN LU, master, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513055
- Sponsor's protocol ID
- ENDO20180205-06
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30341664
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Injection Technique of Premixed Insulin on Glucose Excursion in Type 2 Diabetes Mellitus Using CGMS
- ClinicalTrials.gov ID
- NCT03513055
- Acronym / sponsor ID
- ENDO20180205-06
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- glucose excursions, insulin technique, insulin antibodies, premixed insulin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 7 May 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inject premixed insulin | Experimental | Other: nurse inject premixed insulinpatients inject premixed insulin themselves then nurse inject premixed insulin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse inject premixed insulinnurse inject premixed insulin，coaching in the injection technique | Other | inject premixed insulin |
Primary outcome
The primary endpoint was the relationship between MAGE and injection score
Time frame: 6 DAYS
the relationship between the 24-h mean amplitude of glycemic excursions (MAGE) and injection score
the relationship between HbA1C and injection score
Time frame: 6 DAYS
the relationship between HbA1C and injection score
the relationship between SDBG and injection score
Time frame: 6 DAYS
the relationship between SDBG and injection score
1 secondary outcome
the relation between insulin antibodies and glucose excursions
Time frame: 6 DAYS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 30341664Yuan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YUAN LU, master study director
Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing nurse inject premixed insulin in people with Type2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MA JIANHUA, PHD (+8618951670116, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint was the relationship between MAGE and injection score (time frame: 6 DAYS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.