Type 1 Diabetes MellitusNCT04129424
Preliminary Exploration on the Operational Standards of Insulin Pump Installation in Diabetes Clinic in China
A study testing Insulin pump (Microtech, Equil®) in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Continuous subcutaneous insulin infusion (CSII), known as insulin pump therapy, has been widely used for diabetes patients in recent years. Many clinical studies have proved the priority of CSII to multiple insulin injections including better glycaemic control with lower daily insulin requirement, lower glycated… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational Diabetes Mellitus
- What is being tested?
- Insulin pump (Microtech, Equil®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Dec 2020
- 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
- Patients in clinic of type 1 diabetes mellitus, type 2 diabetes mellitus, gestational/pregestational diabetes mellitus, perioperative diabetes mellitus and patients with diabetes mellitus after pancreatectomy, including those with poor blood glucose control using multiple subcutaneous insulin injections or those are willing to use insulin pump therapy;
- Age: 18-80 years old;
- Patients and family members understand the research program and are willing to participate in the study and sign written informed consent.
Who cannot join
- allergic to dressings and subcutaneous transfusion tubes;
- allergic to insulin;
- Severe diabetic acute complications within 6 months(diabetic ketoacidosis, diabetic hyperglycemia and hyperosmolar state, diabetic lactic acidosis).
- Severe chronic complications of diabetes mellitus, such as peripheral vascular lesions leading to amputation or chronic foot ulcer, end-stage renal disease, etc. who researchers thought not suitable for this study.
- Two or more times of severe hypoglycemia occured in the past year (such as consciousness disturbance and coma caused by hypoglycemia), or severe unconscious hypoglycemia.
- Patients with severe impairment of cardiac function (NYHA grade III or above), liver function (alanine aminotransferase, aspartate aminotransferase or total bilirubin higher than the upper limit of normal value 2 times or more), renal function (serum creatinine higher than the upper limit of normal value) or circulation disorder;
- Patients with mental illness and self-care ability;
- Patients or their families could not understand the conditions and objectives of this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Weigang Zhao, MD, +86 13910054636, xiehezhaoweigang@163.com
About this study
Continuous subcutaneous insulin infusion (CSII), known as insulin pump therapy, has been widely used for diabetes patients in recent years. Many clinical studies have proved the priority of CSII to multiple insulin injections including better glycaemic control with lower daily insulin requirement, lower glycated haemoglobin (HbA1c) level and reduced risk of severe hypoglycaemia. The best mode of CSII is a kind of programmed and individualized insulin infusion mode. But at present, the applying of insulin pump is mainly during hospitalization period in China, which is not conformed with daily living scenarios of patients. The outpatient insulin pump treatment is much closer to the real living scenarios of patients. However, lack of management experience and widely accepted formative model of insulin pump applying in clinic restricted use of insulin pumps in clinical in China. The investigators aimed to explore a safe and effective management mode of insulin pump operating to enable a wide population to have access to daily use of CSII, and to maximize the rational use of limited medical resources.
Read the detailed description
In this study, the investigators plan to enroll patients of different types of diabetes, including type 1 diabetes mellitus, type 2 diabetes mellitus, gestational diabetes mellitus, perioperative diabetes mellitus, pancreatogenic diabetes mellitus (after total pancreatectomy) and diabetes patients in perioperative period，each type of diabetes patients were divided into three groups according to the time (7days, 14days and 28days) reaching the target blood glucose. Those patients are educated to record blood glucose and frequency of hypoglycemia during the study period. After achieving goal blood glucose, follow-up will continue one week to evaluate whether the blood glucose reached our goal and adjust the insulin pump parameter if necessary. The investigators plan to apply continuous glucose monitoring(CGM) for each patient during follow up. The investigators aim to explore the best time to reach goal blood glucose considering frequency of hypoglycemia, economic factors, insulin pump parameters at the end of study and the final insulin pump parameters at the end of follow up. The investigators aim to enroll patients with six different types diabetes because those patients have different insulin secretion pattern, which induced to different mode of CSII. The investigators set the goal fasting blood glucose at 4-6mmol/L and the goal postprandial blood glucose at 6-8mmol/L. The blood glucose of hypoglycemia was lower than 3.9mmol/L.
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational Diabetes Mellitus, Pancreatogenic Diabetes Mellitus, Pregestational Diabetes Mellitus, Diabetes Patients in Perioperative Period
- Being tested
- Insulin pump (Microtech, Equil®)
- Keywords
- Diabetes mellitus, Insulin pump, Continuous subcutaneous insulin infusion
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pump (Microtech, Equil®)Device
Those patients of different types of diabetes mellitus were assigned to different groups, those groups were classified by the time to reach target blood glucose .
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes mellitus_7-day group | Experimental | Type 1 diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Type 1 diabetes mellitus_14-day group | Experimental | Type 1 diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Type 1 diabetes mellitus_28-day group | Experimental | Type 1 diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Type 2 diabetes mellitus_7-day group | Experimental | Type 2 diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Type 2 diabetes mellitus_14-day group | Experimental | Type 2 diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Type 2 diabetes mellitus_28-day group | Experimental | Type 2 diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Gestational diabetes mellitus_7-day group | Experimental | Gestational diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Gestational diabetes mellitus_14-day group | Experimental | Gestational diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Gestational diabetes mellitus_28-day group | Experimental | Gestational diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Pregestational diabetes mellitus_7-day group | Experimental | Pregestational diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Pregestational diabetes mellitus_14-day group | Experimental | Pregestational diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Pregestational diabetes mellitus_28-day group | Experimental | Pregestational diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Pancreatogenic diabetes mellitus _7-day group | Experimental | Pancreatogenic diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Pancreatogenic diabetes mellitus _14-day group | Experimental | Pancreatogenic diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Pancreatogenic diabetes mellitus _28-day group | Experimental | Pancreatogenic diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Diabetes patients in perioperative period _7-day group | Experimental | Diabetes patients in perioperative period aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Diabetes patients in perioperative period _14-day group | Experimental | Diabetes patients in perioperative period aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
| Diabetes patients in perioperative period _28-day group | Experimental | Diabetes patients in perioperative period aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. Receives: Device: Insulin pump (Microtech, Equil®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The basal insulin dose of insulin pump at the end of the study
Measured: Day-7 or day-14 or day-28 for different groups
The preprandial insulin dose of insulin pump at the end of the study
Measured: Day-7 or day-14 or day-28 for different groups
The basal insulin dose of insulin pump at the end of the 6-day follow-up
Measured: Day-14 or day-28 or day-35 for different groups
The preprandial insulin dose of insulin pump at the end of the 6-day follow-up
Measured: Day-14 or day-28 or day-35 for different groups
Secondary outcomes (9)
The frequency of hypoglycemia
Measured: Day-7 or day-14 or day-28 for different groups
The time in range of goal blood glucose during follow-up
Measured: Day-14 or day-28 or day-35 for different groups
The frequency of pain at puncture site
Measured: Day-7 or day-14 or day-28 for different groups
The frequency of errors in patency of infusion pipeline connection
Measured: Day-7 or day-14 or day-28 for different groups
The blood glucose value of hypoglycemia
Measured: Day-7 or day-14 or day-28 for different groups
The symptoms of hypoglycemia
Measured: Day-7 or day-14 or day-28 for different groups
The frequency of bleeding at puncture site
Measured: Day-7 or day-14 or day-28 for different groups
The frequency of infection at puncture site
Measured: Day-7 or day-14 or day-28 for different groups
The frequency of errors in patency of needle fixation
Measured: Day-7 or day-14 or day-28 for different groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129424
- Sponsor's protocol ID
- Zhao insulin pump
- Status last verified
- Oct 2019
- First submitted
- 20 Sep 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Exploration on the Operational Standards of Insulin Pump Installation in Diabetes Clinic in China
- ClinicalTrials.gov ID
- NCT04129424
- Acronym / sponsor ID
- Zhao insulin pump
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational Diabetes Mellitus, Pancreatogenic Diabetes Mellitus, Pregestational Diabetes Mellitus, Diabetes Patients in Perioperative Period
- Keywords
- Diabetes mellitus, Insulin pump, Continuous subcutaneous insulin infusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 16 Oct 2019 (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.
Continuous subcutaneous insulin infusion (CSII), known as insulin pump therapy, has been widely used for diabetes patients in recent years. Many clinical studies have proved the priority of CSII to multiple insulin injections including better glycaemic control with lower daily insulin requirement, lower glycated haemoglobin (HbA1c) level and reduced risk of severe hypoglycaemia. The best mode of CSII is a kind of programmed and individualized insulin infusion mode. But at present, the applying of insulin pump is mainly during hospitalization period in China, which is not conformed with daily living scenarios of patients. The outpatient insulin pump treatment is much closer to the real living scenarios of patients. However, lack of management experience and widely accepted formative model of insulin pump applying in clinic restricted use of insulin pumps in clinical in China. The investigators aimed to explore a safe and effective management mode of insulin pump operating to enable a wide population to have access to daily use of CSII, and to maximize the rational use of limited medical resources.
Detailed description
In this study, the investigators plan to enroll patients of different types of diabetes, including type 1 diabetes mellitus, type 2 diabetes mellitus, gestational diabetes mellitus, perioperative diabetes mellitus, pancreatogenic diabetes mellitus (after total pancreatectomy) and diabetes patients in perioperative period，each type of diabetes patients were divided into three groups according to the time (7days, 14days and 28days) reaching the target blood glucose. Those patients are educated to record blood glucose and frequency of hypoglycemia during the study period. After achieving goal blood glucose, follow-up will continue one week to evaluate whether the blood glucose reached our goal and adjust the insulin pump parameter if necessary. The investigators plan to apply continuous glucose monitoring(CGM) for each patient during follow up. The investigators aim to explore the best time to reach goal blood glucose considering frequency of hypoglycemia, economic factors, insulin pump parameters at the end of study and the final insulin pump parameters at the end of follow up. The investigators aim to enroll patients with six different types diabetes because those patients have different insulin secretion pattern, which induced to different mode of CSII. The investigators set the goal fasting blood glucose at 4-6mmol/L and the goal postprandial blood glucose at 6-8mmol/L. The blood glucose of hypoglycemia was lower than 3.9mmol/L.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes mellitus_7-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Type 1 diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Type 1 diabetes mellitus_14-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Type 1 diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Type 1 diabetes mellitus_28-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Type 1 diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Type 2 diabetes mellitus_7-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Type 2 diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Type 2 diabetes mellitus_14-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Type 2 diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Type 2 diabetes mellitus_28-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Type 2 diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Gestational diabetes mellitus_7-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Gestational diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Gestational diabetes mellitus_14-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Gestational diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Gestational diabetes mellitus_28-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Gestational diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Pregestational diabetes mellitus_7-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Pregestational diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Pregestational diabetes mellitus_14-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Pregestational diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Pregestational diabetes mellitus_28-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Pregestational diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Pancreatogenic diabetes mellitus _7-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Pancreatogenic diabetes mellitus patients aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Pancreatogenic diabetes mellitus _14-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Pancreatogenic diabetes mellitus patients aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Pancreatogenic diabetes mellitus _28-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Pancreatogenic diabetes mellitus patients aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Diabetes patients in perioperative period _7-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Diabetes patients in perioperative period aimed to reach goal blood glucose in 7 days. After 7 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Diabetes patients in perioperative period _14-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Diabetes patients in perioperative period aimed to reach goal blood glucose in 14 days. After 14 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
| Diabetes patients in perioperative period _28-day group | Experimental | Device: Insulin pump (Microtech, Equil®)Diabetes patients in perioperative period aimed to reach goal blood glucose in 28 days. After 28 days, CGM was planed to apply for another 6 days to evaluate their blood glucose level and adjust insulin dose if necessary. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in clinic of type 1 diabetes mellitus, type 2 diabetes mellitus, gestational/pregestational diabetes mellitus, perioperative diabetes mellitus and patients with diabetes mellitus after pancreatectomy, including those with poor blood glucose control using multiple subcutaneous insulin injections or those are willing to use insulin pump therapy;
- Age: 18-80 years old;
- Patients and family members understand the research program and are willing to participate in the study and sign written informed consent.
Key exclusion criteria (8 listed)
- allergic to dressings and subcutaneous transfusion tubes;
- allergic to insulin;
- Severe diabetic acute complications within 6 months(diabetic ketoacidosis, diabetic hyperglycemia and hyperosmolar state, diabetic lactic acidosis).
- Severe chronic complications of diabetes mellitus, such as peripheral vascular lesions leading to amputation or chronic foot ulcer, end-stage renal disease, etc. who researchers thought not suitable for this study.
- Two or more times of severe hypoglycemia occured in the past year (such as consciousness disturbance and coma caused by hypoglycemia), or severe unconscious hypoglycemia.
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 |
|---|---|---|
| Insulin pump (Microtech, Equil®)Those patients of different types of diabetes mellitus were assigned to different groups, those groups were classified by the time to reach target blood glucose . | Device | Diabetes patients in perioperative period _14-day group, Diabetes patients in perioperative period _28-day group, Diabetes patients in perioperative period _7-day group, Gestational diabetes mellitus_14-day group, Gestational diabetes mellitus_28-day group, Gestational diabetes mellitus_7-day group, Pancreatogenic diabetes mellitus _14-day group, Pancreatogenic diabetes mellitus _28-day group, Pancreatogenic diabetes mellitus _7-day group, Pregestational diabetes mellitus_14-day group, Pregestational diabetes mellitus_28-day group, Pregestational diabetes mellitus_7-day group, Type 1 diabetes mellitus_14-day group, Type 1 diabetes mellitus_28-day group, Type 1 diabetes mellitus_7-day group, Type 2 diabetes mellitus_14-day group, Type 2 diabetes mellitus_28-day group, Type 2 diabetes mellitus_7-day group |
Primary outcome
The basal insulin dose of insulin pump at the end of the study
Time frame: Day-7 or day-14 or day-28 for different groups
The preprandial insulin dose of insulin pump at the end of the study
Time frame: Day-7 or day-14 or day-28 for different groups
The basal insulin dose of insulin pump at the end of the 6-day follow-up
Time frame: Day-14 or day-28 or day-35 for different groups
The preprandial insulin dose of insulin pump at the end of the 6-day follow-up
Time frame: Day-14 or day-28 or day-35 for different groups
9 secondary outcomes
The frequency of hypoglycemia
Time frame: Day-7 or day-14 or day-28 for different groups
The time in range of goal blood glucose during follow-up
Time frame: Day-14 or day-28 or day-35 for different groups
The frequency of pain at puncture site
Time frame: Day-7 or day-14 or day-28 for different groups
The frequency of errors in patency of infusion pipeline connection
Time frame: Day-7 or day-14 or day-28 for different groups
The blood glucose value of hypoglycemia
Time frame: Day-7 or day-14 or day-28 for different groups
The symptoms of hypoglycemia
Time frame: Day-7 or day-14 or day-28 for different groups
The frequency of bleeding at puncture site
Time frame: Day-7 or day-14 or day-28 for different groups
The frequency of infection at puncture site
Time frame: Day-7 or day-14 or day-28 for different groups
The frequency of errors in patency of needle fixation
Time frame: Day-7 or day-14 or day-28 for different groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin pump (Microtech, Equil®) in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Peking Union Medical College Hospital at 1 site in China.
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 3 inclusion and 8 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 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Weigang Zhao, MD (+86 13910054636, xiehezhaoweigang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The basal insulin dose of insulin pump at the end of the study (time frame: Day-7 or day-14 or day-28 for different groups). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2019.