DiabetesNCT01213901
Optimizing Insulin Absorption and Insulin Injection Technique in Older Adults
A study testing Lispro insulin in people with Diabetes, run by University of British Columbia at 1 site in Canada.
Trial summary
To determine which anatomic site offers the most consistent (superior) absorption of insulin. To determine the injection technique which allows the most consistent subcutaneous injection of insulin (to pinch or to spread). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Lispro insulin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Mar 2014
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male or female over the age of 70
- Type 2 diabetes
- Insulin naive - never have taken insulin with the exception of a short course during a hospitalization or illness
- A1C between .065-.085
- BMI between 25 and 35
Who cannot join
- hemoglobin below 130g/L (males) and below 120g/L (females)
- taking medications that are known to interfere with glucose metabolism: systemic corticosteroids, non selective beta blockers
- Impaired liver function as shown by but not limited to AST and/or ALT > 2 times the upper limit of normal
- impaired renal function as shown by but not limited to serum creatinine > 133micromoles/L (males) and 124 micromoles/L (female)
- participation in another clinical trial within the past 30 days
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vitality Research Centre - Vancouver General Hospital
Vancouver, British Columbia
About this study
To determine which anatomic site offers the most consistent (superior) absorption of insulin.
To determine the injection technique which allows the most consistent subcutaneous injection of insulin (to pinch or to spread).
Read more
Hypothesis:
Based on age-related changes in the amount of subcutaneous fat we anticipate that the absorption of insulin from various anatomical sites will differ.
Justification:
To date health care professionals have extrapolated data obtained from younger adults and applied the results to the elderly.
Objectives:
To determine the rate of insulin absorption from different anatomic sites in diabetic patients over the age of 70.
To determine the best practice for subcutaneous injection in older adults.
Research Method:
Measurement of serial glucose and insulin levels using 360 minute euglycemic clamp studies.
Statistical Analysis:
Paired t test, repeated measures ANOVA
Read the detailed description
The study will consist of 5 visits to the UBC VITALiTY Research Centre. At the screening visit subjects will have the following information collected: height, weight, blood pressure, heart rate, BMI, medical history and concommitant medications. Approximately 15cc of blood will be drawn and analyzed for A1C, CBC with platelets, AST, ALT, alk phos, BUN, creatinine, fasting blood sugar.
The subjects will undergo 4 euglycemic clamp studies at least 30 days apart in random order. During one study subjects will receive the insulin injection in the abdomen using the pinch technique. In another study the subjects will receive the insulin injection using the spread technique. During a third study the subjects will receive the insulin injection in the deltiod area using the pinch technique. During a fourth study the subjects will receive the insulin injection in the deltoid using the spread technique. Subjects will be randomly assigned to the studies. After each injection the subject will complete a questionnaire to rate comfort of the injection.
Subjects will report to the Research Centre at 0700 having fasted since midnight the night before. An intravenous line with normal saline will be placed in one hand to facilitate blood drawing. This hand will be placed in a heated box. A second intravenous will be inserted in the arm for the infusion of glucose.
Prior to subcutaneous insulin injection, blood samples will be collected at -30, -15, and 0 minutes. At time 0 the subcutaneous injection of lispro insulin (0.1 u/kg)will be administered and the glucose infusion will be started. Glucose levels will be measured at the bedside every 5 min and insulin levels every 15 min from 0-360 min. Glucose infusion will be adjusted to maintain glucose levels at a constant level for the duration of the study, using the glucose clamp protocol.
- Conditions
- Diabetes
- Being tested
- Lispro insulin
- Keywords
- Insulin absorption, Insulin injection technique
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lispro insulinProcedure or surgery
Each patient will receive 2 insulin injections in the abdomen: Once using a pinch method and once using a spread method.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Each patient will receive 2 insulin injections in the abdomen: Once using a pinch method and once using a spread method.
Injections will be given in a random order and the technician will be blinded to the injection.
Each patient will evaluate the comfort of the injection by completing a visual analog scale. Receives: Procedure: Lispro insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic site, abdomen versus deltoid, that offers the most consistent(superior) absorption of insulin
Secondary outcomes (1)
Injection technique which allows the most comfortable method of inserting the needle subcutaneously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2012
- Study completionMar 2014
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 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Graydon Meneilly, University of British Columbia
- Investigators
- Gale Tedder, Study director, Vancouver Coastal Health Research InstituteChris Lockhart, Study director, Vancouver Coastal Health Research InstituteLee Ann Trimble, Study director, Vancouver Coastal Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213901
- Sponsor's protocol ID
- H10-00462
- Status last verified
- Jan 2018
- First submitted
- 29 Sep 2010
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Trimble LA, Meneilly GS. Optimizing insulin absorption and insulin injection technique in older adults. Diabetes Care. 2014 Jun;37(6):e127-8. doi: 10.2337/dc14-0086. No abstract available.
PubMed 24855165
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Insulin Absorption and Insulin Injection Technique in Older Adults
- ClinicalTrials.gov ID
- NCT01213901
- Acronym / sponsor ID
- H10-00462
- Conditions
- Diabetes
- Keywords
- Insulin absorption, Insulin injection technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Oct 2010 (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.
To determine which anatomic site offers the most consistent (superior) absorption of insulin.
To determine the injection technique which allows the most consistent subcutaneous injection of insulin (to pinch or to spread).
Hypothesis:
Based on age-related changes in the amount of subcutaneous fat we anticipate that the absorption of insulin from various anatomical sites will differ.
Justification:
To date health care professionals have extrapolated data obtained from younger adults and applied the results to the elderly.
Objectives:
To determine the rate of insulin absorption from different anatomic sites in diabetic patients over the age of 70.
To determine the best practice for subcutaneous injection in older adults.
Research Method:
Measurement of serial glucose and insulin levels using 360 minute euglycemic clamp studies.
Statistical Analysis:
Paired t test, repeated measures ANOVA
Detailed description
The study will consist of 5 visits to the UBC VITALiTY Research Centre. At the screening visit subjects will have the following information collected: height, weight, blood pressure, heart rate, BMI, medical history and concommitant medications. Approximately 15cc of blood will be drawn and analyzed for A1C, CBC with platelets, AST, ALT, alk phos, BUN, creatinine, fasting blood sugar.
The subjects will undergo 4 euglycemic clamp studies at least 30 days apart in random order. During one study subjects will receive the insulin injection in the abdomen using the pinch technique. In another study the subjects will receive the insulin injection using the spread technique. During a third study the subjects will receive the insulin injection in the deltiod area using the pinch technique. During a fourth study the subjects will receive the insulin injection in the deltoid using the spread technique. Subjects will be randomly assigned to the studies. After each injection the subject will complete a questionnaire to rate comfort of the injection.
Subjects will report to the Research Centre at 0700 having fasted since midnight the night before. An intravenous line with normal saline will be placed in one hand to facilitate blood drawing. This hand will be placed in a heated box. A second intravenous will be inserted in the arm for the infusion of glucose.
Prior to subcutaneous insulin injection, blood samples will be collected at -30, -15, and 0 minutes. At time 0 the subcutaneous injection of lispro insulin (0.1 u/kg)will be administered and the glucose infusion will be started. Glucose levels will be measured at the bedside every 5 min and insulin levels every 15 min from 0-360 min. Glucose infusion will be adjusted to maintain glucose levels at a constant level for the duration of the study, using the glucose clamp protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Lispro insulinEach patient will receive 2 insulin injections in the abdomen: Once using a pinch method and once using a spread method. Injections will be given in a random order and the technician will be blinded to the injection. Each patient will evaluate the comfort of the injection by completing a visual analog scale. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male or female over the age of 70
- Type 2 diabetes
- Insulin naive - never have taken insulin with the exception of a short course during a hospitalization or illness
- A1C between .065-.085
- BMI between 25 and 35
Key exclusion criteria (5 listed)
- hemoglobin below 130g/L (males) and below 120g/L (females)
- taking medications that are known to interfere with glucose metabolism: systemic corticosteroids, non selective beta blockers
- Impaired liver function as shown by but not limited to AST and/or ALT > 2 times the upper limit of normal
- impaired renal function as shown by but not limited to serum creatinine > 133micromoles/L (males) and 124 micromoles/L (female)
- participation in another clinical trial within the past 30 days
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 |
|---|---|---|
| Lispro insulinEach patient will receive 2 insulin injections in the abdomen: Once using a pinch method and once using a spread method. | Procedure or surgery | 1 |
Primary outcome
Anatomic site, abdomen versus deltoid, that offers the most consistent(superior) absorption of insulin
1 secondary outcome
Injection technique which allows the most comfortable method of inserting the needle subcutaneously
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 18 Jan 2018.
- Derived from this study: PubMed 24855165Trimble LA, Meneilly GS. Optimizing insulin absorption and insulin injection technique in older adults. Diabetes Care. 2014 Jun;37(6):e127-8. doi: 10.2337/dc14-0086. No abstract available.
Related trials for Diabetes
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
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.
Gale Tedder study director
Vancouver Coastal Health Research Institute
Chris Lockhart study director
Vancouver Coastal Health Research Institute
Lee Ann Trimble study director
Vancouver Coastal Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lispro insulin in people with Diabetes, run by University of British Columbia at 1 site in Canada.
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 5 inclusion and 5 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 18 Jan 2018. 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 Canada. 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?
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?
Anatomic site, abdomen versus deltoid, that offers the most consistent(superior) absorption of insulin. 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 NCT01213901, 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 18 Jan 2018.