Diabetes Mellitus, Type 2NCT02910141
Individual Patient Data Meta-analysis of CSII vs. MDI in Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2, run by King's College London.
Trial summary
This study aims to compare glycaemic control during continuous subcutaneous insulin fusion (CSII, insulin pump therapy) and multiple daily insulin injections in type 2 diabetes and to identify patient-level characteristics that predict the best improvement in control and any change in insulin dose or other outcome. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Continuous subcutaneous insulin infusion
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 590 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with type 2 diabetes
Who may be able to join
- RCTs of CSII vs. MDI in type 2 diabetes, study duration at least 2 months, non-pregnant
Who cannot join
- Type 1 diabetes, studies <2 months duration, pregnant women, newly diagnosed type 2 diabetes and extensions of previous studies.
About this study
Official title: Individual Patient Data Meta-analysis of Randomised Controlled Trials Comparing Glycaemic Control During Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Insulin Injections in Type 2 Diabetes Mellitus
This study aims to compare glycaemic control during continuous subcutaneous insulin fusion (CSII, insulin pump therapy) and multiple daily insulin injections in type 2 diabetes and to identify patient-level characteristics that predict the best improvement in control and any change in insulin dose or other outcome.
Read the detailed description
The investigators will identify randomised controlled trials without language restriction that meet the inclusion criteria by searching the Cochrane database, Ovid Medline, Google Scholar and other sources. The investigators will exclude observational studies, short-term trials <2 months duration, studies in pregnant diabetic subjects, newly diagnosed type 2 diabetes, trials in type 1 diabetes and extensions of previous studies.
Data on individual participants will be obtained directly from trialists and from funding sponsors who hold the trial data and will include age, sex, duration of diabetes, treatment group, baseline and final HbA1c, baseline and final insulin dose, baseline and final BMI.
A 'two-step' meta-analysis will be performed to estimate overall mean differences in HbA1c, insulin dose and weight/BMI for the trials. Then, a 'one-step' meta-regression analysis will be conducted by creating a single large dataset from the individual patient data. Determinants of final HbA1c, BMI/weight and insulin dose will be explored using Bayesian approaches with covariates that include baseline HbA1c, age, diabetes duration, BMI, insulin dose and interactions between the covariates.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Continuous subcutaneous insulin infusion
- Keywords
- Type 2 diabetes, Continuous subcutaneous insulin infusion, Meta-analysis, Insulin pump therapy, Multiple daily insulin injections
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous subcutaneous insulin infusionDevice
Also called Insulin pump therapy
Infusion of short-acting insulin from a portable pump
| Study group | Role | What they receive |
|---|---|---|
| CSII (subcutaneous insulin infusion) | People with Type 2 diabetes treated by continuous subcutaneous insulin infusion (CSII) Receives: Device: Continuous subcutaneous insulin infusion | |
| MDI (multiple daily insulin injections) | People with type 2 diabetes treated by multiple daily insulin injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Difference in glycaemic control between treatments, as measured by HbA1c
Measured: Up to 24 months
Secondary outcomes (2)
Insulin dose
Difference in insulin dose between treatments
Measured: Up to 24 months
Weight or BMI
Difference in weight or BMI between treatments
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionDec 2016
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, University Hospital, Caen
- Responsible party
- Principal investigator, Professor John Pickup, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910141
- Sponsor's protocol ID
- IPDMetaT2
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Pickup JC, Reznik Y, Sutton AJ. Glycemic Control During Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Insulin Injections in Type 2 Diabetes: Individual Patient Data Meta-analysis and Meta-regression of Randomized Controlled Trials. Diabetes Care. 2017 May;40(5):715-722. doi: 10.2337/dc16-2201.
PubMed 28428322
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Data Meta-analysis of Randomised Controlled Trials Comparing Glycaemic Control During Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Insulin Injections in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02910141
- Acronym / sponsor ID
- IPDMetaT2
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, Continuous subcutaneous insulin infusion, Meta-analysis, Insulin pump therapy, Multiple daily insulin injections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Leicester, University Hospital, Caen
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Sep 2016 (estimated)
- 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.
This study aims to compare glycaemic control during continuous subcutaneous insulin fusion (CSII, insulin pump therapy) and multiple daily insulin injections in type 2 diabetes and to identify patient-level characteristics that predict the best improvement in control and any change in insulin dose or other outcome.
Detailed description
The investigators will identify randomised controlled trials without language restriction that meet the inclusion criteria by searching the Cochrane database, Ovid Medline, Google Scholar and other sources. The investigators will exclude observational studies, short-term trials <2 months duration, studies in pregnant diabetic subjects, newly diagnosed type 2 diabetes, trials in type 1 diabetes and extensions of previous studies.
Data on individual participants will be obtained directly from trialists and from funding sponsors who hold the trial data and will include age, sex, duration of diabetes, treatment group, baseline and final HbA1c, baseline and final insulin dose, baseline and final BMI.
A 'two-step' meta-analysis will be performed to estimate overall mean differences in HbA1c, insulin dose and weight/BMI for the trials. Then, a 'one-step' meta-regression analysis will be conducted by creating a single large dataset from the individual patient data. Determinants of final HbA1c, BMI/weight and insulin dose will be explored using Bayesian approaches with covariates that include baseline HbA1c, age, diabetes duration, BMI, insulin dose and interactions between the covariates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSII (subcutaneous insulin infusion) | – | Device: Continuous subcutaneous insulin infusionPeople with Type 2 diabetes treated by continuous subcutaneous insulin infusion (CSII) |
| MDI (multiple daily insulin injections) | – | –People with type 2 diabetes treated by multiple daily insulin injections |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with type 2 diabetes
Key inclusion criteria (1 listed)
- RCTs of CSII vs. MDI in type 2 diabetes, study duration at least 2 months, non-pregnant
Key exclusion criteria (1 listed)
- Type 1 diabetes, studies <2 months duration, pregnant women, newly diagnosed type 2 diabetes and extensions of previous studies.
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 |
|---|---|---|
| Continuous subcutaneous insulin infusionAlso: Insulin pump therapyInfusion of short-acting insulin from a portable pump | Device | CSII (subcutaneous insulin infusion) |
Primary outcome
HbA1c
Time frame: Up to 24 months
Difference in glycaemic control between treatments, as measured by HbA1c
2 secondary outcomes
Insulin dose
Time frame: Up to 24 months
Weight or BMI
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 28428322Pickup JC, Reznik Y, Sutton AJ. Glycemic Control During Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Insulin Injections in Type 2 Diabetes: Individual Patient Data Meta-analysis and Meta-regression of Randomized Controlled Trials. Diabetes Care. 2017 May;40(5):715-722. doi: 10.2337/dc16-2201.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by King's College London.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Up to 24 months). 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 NCT02910141, 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 3 Mar 2017.