Diabetes MellitusISMASNCT00506272
Inpatient Self Monitoring and Administration Study (ISMAS)
A study testing Self blood glucose monitoring and insulin administration in people with Diabetes Mellitus and Hyperglycemia, run by Atlanta VA Medical Center at 1 site in United States.
Trial summary
ISMAS is designed to test the hypothesis that self management of insulin dependent diabetes mellitus by selected patients admitted for elective surgery is more efficacious than standard care with respect to overall glycemic control, attaining finger-stick blood sugars, and administering insulin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- What is being tested?
- Self blood glucose monitoring and insulin administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2016
- 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
- Male or female, age < 80
- Most recent hemoglobin A1C within the past 6 months < 12%
- Recent history of regular self-administered peripheral blood glucose checks as an outpatient
- Recent history of insulin self-administration at least twice a day as an outpatient
- Admitted for a hospitalization anticipated to last at least 3 days
- Mini Mental Status Examination (MMSE) ≥ 25 at admission and the same or better post-operatively
- All patients will be actively followed by the Endocrinology inpatient consultation team during the hospitalization.
Who cannot join
- Currently receiving peritoneal or hemodialysis
- Patients with unstable angina
- History of myocardial infarction within 3 weeks prior to enrollment
- Current admission due to or associated with altered mental status or encephalopathy
- History of an episode of altered mental status or encephalopathy within the 4 weeks prior to enrollment
- A confirmed diagnosis of dementia
Show all 11Show fewer
- Inability to self-adjust insulin
- No recent history of ability to perform regular peripheral blood glucose checks
- Frequency of hypoglycemia (< 60 mg/dL) > twice/week by history
- Inability to eat without assistance
- Study objectives will not be pursued in patients during stays in any intensive care unit.
Trial locations and contacts
1 site in 1 country.
About this study
ISMAS is designed to test the hypothesis that self management of insulin dependent diabetes mellitus by selected patients admitted for elective surgery is more efficacious than standard care with respect to overall glycemic control, attaining finger-stick blood sugars, and administering insulin.
- Conditions
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- Being tested
- Self blood glucose monitoring and insulin administration, Standard care
- Keywords
- diabetes mellitus, hyperglycemia, hypoglycemia, self care
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self blood glucose monitoring and insulin administrationProcedure or surgery
Patients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin
Standard careProcedure or surgery
finger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Experimental | Patients admitted for elective surgery will receive standard diabetes care, including but not limited to finger stick blood glucose determinations, and insulin injections delivered by the nursing staff. Receives: Procedure: Standard care |
| Patient administered care | Experimental | Patients will self-monitor and record finger-stick blood glucose measurements, and self administer insulin at doses agreed upon with the consulting endocrinology in-patient service. Receives: Procedure: Self blood glucose monitoring and insulin administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of blood glucose measurements obtained/number of blood glucose measurements ordered
Measured: patients will be followed for the duration of hospital stay, an expected average of 5 days
number of insulin doses administered/number of insulin doses prescribed
Measured: patients will be followed for the duration of hospital stay, an expected average of 5 days
average blood glucose
Measured: patients will be followed for the duration of hospital stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlanta VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Peter Thule, Atlanta VA Medical Center
- Investigators
- Peter M Thule, MD, Principal investigator, Atlanta VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506272
- Sponsor's protocol ID
- Emory IRB: 805-2006
- Acronym
- ISMAS
- Status last verified
- Dec 2015
- First submitted
- 23 Jul 2007
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Self Monitoring and Administration Study (ISMAS)
- ClinicalTrials.gov ID
- NCT00506272
- Acronym / sponsor ID
- ISMAS / Emory IRB: 805-2006
- Conditions
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
- Keywords
- diabetes mellitus, hyperglycemia, hypoglycemia, self care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Atlanta VA Medical CenterUS federal agency
- Study start
- Dec 2007
- Primary completion
- Dec 2016 (estimated)
- First posted
- 25 Jul 2007 (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.
ISMAS is designed to test the hypothesis that self management of insulin dependent diabetes mellitus by selected patients admitted for elective surgery is more efficacious than standard care with respect to overall glycemic control, attaining finger-stick blood sugars, and administering insulin.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Experimental | Procedure: Standard carePatients admitted for elective surgery will receive standard diabetes care, including but not limited to finger stick blood glucose determinations, and insulin injections delivered by the nursing staff. |
| Patient administered care | Experimental | Procedure: Self blood glucose monitoring and insulin administrationPatients will self-monitor and record finger-stick blood glucose measurements, and self administer insulin at doses agreed upon with the consulting endocrinology in-patient service. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, age < 80
- Most recent hemoglobin A1C within the past 6 months < 12%
- Recent history of regular self-administered peripheral blood glucose checks as an outpatient
- Recent history of insulin self-administration at least twice a day as an outpatient
- Admitted for a hospitalization anticipated to last at least 3 days
Key exclusion criteria (11 listed)
- Currently receiving peritoneal or hemodialysis
- Patients with unstable angina
- History of myocardial infarction within 3 weeks prior to enrollment
- Current admission due to or associated with altered mental status or encephalopathy
- History of an episode of altered mental status or encephalopathy within the 4 weeks prior to enrollment
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 |
|---|---|---|
| Self blood glucose monitoring and insulin administrationPatients will monitor blood glucose using a hand-held blood glucose monitor, and self-administer insulin | Procedure or surgery | Patient administered care |
| Standard carefinger-stick blood glucose values to be obtained and all insulin administration to be delivered by nursing staff | Procedure or surgery | Standard care |
Primary outcome
number of blood glucose measurements obtained/number of blood glucose measurements ordered
Time frame: patients will be followed for the duration of hospital stay, an expected average of 5 days
number of insulin doses administered/number of insulin doses prescribed
Time frame: patients will be followed for the duration of hospital stay, an expected average of 5 days
average blood glucose
Time frame: patients will be followed for the duration of hospital stay, an expected average of 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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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.
Peter M Thule, MD principal investigator
Atlanta VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self blood glucose monitoring and insulin administration in people with Diabetes Mellitus and Hyperglycemia, run by Atlanta VA Medical Center at 1 site in United States.
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 11 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 14 Dec 2015. 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 United States. 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?
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?
number of blood glucose measurements obtained/number of blood glucose measurements ordered (time frame: patients will be followed for the duration of hospital stay, an expected average of 5 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?
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 14 Dec 2015.