Diabetes MellitusNCT02144441
Pilot Study of Clinician-supported Patient Self-management of Hospital Insulin Therapy
A study testing glargine and aspart in people with Diabetes Mellitus, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will examine the feasibility of implementing a clinician-supported patient self-managed inpatient insulin intervention. It will: assess the number of eligible patients presenting over time; assess patients' willingness to enroll; assess patients' ability to successfully complete the intervention; examine… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- glargine and aspart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the Hospital of the University of Pennsylvania (HUP) in the past 72 hours.
- Current HUP locations are Founders 12, Founders 14, Silverstein 11, and Rhoads 1.
- Age 18 years or older.
- Type-1 or type-2 diabetes mellitus requiring home basal-bolus insulin therapy administered via subcutaneous injection (not pump).
- Patient manages own basal-bolus insulin therapy at home without assistance, including measuring own blood glucose (at least at mealtimes) and administering own subcutaneous insulin.
- Patient is willing to use the following insulin products: rapid-acting insulin aspart via insulin pen (NovoLog) and long-acting insulin glargine via vial and syringe (Lantus).
Show all 10Show fewer
- Most recent hemoglobin A1c was measured within past 6 months and was <7.5%.
- Active order for in-hospital basal-bolus or sliding-scale insulin.
- Patient is willing and able to record their self-measured blood glucose results, doses of insulin that they self-administer, a food journal, and exercise log.
- Clinical care team agrees with study inclusion.
Who cannot join
- Inpatient order for insulin via subcutaneous infusion (i.e., pump) or intravenous infusion (i.e., drip).
- Inability to perform the activities required by the trial.
- Primary reason for admission was hyperglycemia, hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic coma, a psychiatric condition, acute alcohol poisoning, or acute drug ingestion.
- Order for a newly-prescribed or increased dose of a previously-prescribed corticosteroid.
- Enteral or parenteral nutrition.
- Expected length of stay <48h, as determined by treating physician.
Show all 15Show fewer
- At risk for self-harm, as determined by 1-to-1 status placement.
- Pregnant, as recorded on medical record.
- Cannot understand, speak, and read English.
- Patient does not wish to utilize Novolog and Lantus while in the hospital.
- Prior enrollment in this trial.
- Do not resuscitate status.
- Inability to give written informed consent.
- Clinical care team disagrees with study inclusion.
- Patient has limited mobility such that they cannot safely access the bedside medication lockbox.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Proof-of-concept Trial of Clinician-supported Patient Self-management of Hospital Insulin Therapy
This study will examine the feasibility of implementing a clinician-supported patient self-managed inpatient insulin intervention. It will: assess the number of eligible patients presenting over time; assess patients' willingness to enroll; assess patients' ability to successfully complete the intervention; examine occurrences of hyperglycemia and hypoglycemia; and assess patients' satisfaction with inpatient diabetes care.
- Conditions
- Diabetes Mellitus
- Being tested
- glargine and aspart
- Keywords
- Diabetes Mellitus, Insulin, Self Administration, Patient Satisfaction, Glucose, Hypoglycemia, Hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance, Patient Satisfaction, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glargine and aspartDrug
Inpatient will administer hospital-dispensed basal-bolus insulin (glargine and aspart) according to a regimen developed in collaboration with the diabetes consult service.
| Study group | Role | What they receive |
|---|---|---|
| Patient self-administered insulin | Experimental | The study's only arm Receives: Drug: glargine and aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial feasibility metric: number of screened patients
Measured: 3 months
Trial feasibility metric: number of eligible patients
Measured: 3 months
Trial feasibility metric: number of patients approached for consent
Measured: 3 months
Trial feasibility metric: proportion of eligible patients not consenting
Measured: 3 months
Trial feasibility metric: reasons for non-consent
Measured: 3 months
Trial feasibility metric: characteristics of consenting subjects and non-consenting patients
To examine baseline demographics and clinical factors, such as: mean age, median age, proportion female sex, other demographics, proportion with type I diabetes, proportion with type II diabetes, hemoglobin A1c on admission, reasons for admission
Measured: 3 months
Trial feasibility metric: proportion of enrolled subjects completing the intervention
Measured: 3 months
Trial feasibility metric: proportion of enrolled subjects disenrolling
Measured: 3 months
Trial feasibility metric: reasons for disenrollment
Measured: 3 months
Secondary outcomes (3)
Hyperglycemia
Frequency of blood glucose concentrations that are hyperglycemic (> 180 mg/dL)
Measured: During hospitalization (maximum length 7 days)
Patient satisfaction
Satisfaction with inpatient diabetes care, as measured by the Diabetes Treatment Satisfaction Questionnaire for Inpatients (DTSQ-IP) adapted for use in the United States
Measured: At the end of hospitalization (maximum length 7 days)
Hypoglycemia
Frequency of hypoglycemia (blood glucose concentration < 70 mg/dL) and frequency of severe hypoglycemia (blood glucose concentration < 40 mg/dL)
Measured: During hospitalization (maximum length 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Very few patients met eligibility criteria, none of whom elected to enroll.
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 MellitusStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Hennessy, PharmD, PhD, Principal investigator, Perelman School of Medicine at the University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144441
- Sponsor's protocol ID
- 819840
- Status last verified
- May 2014
- First submitted
- 13 May 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Acton EK, Leonard CE, Schutta MH, Cardillo S, Troxel AB, Trotta R, Hennessy S. Challenges in recruiting subjects to a pilot trial of patient-managed in-hospital insulin. BMC Res Notes. 2015 Oct 1;8:523. doi: 10.1186/s13104-015-1480-6.
PubMed 26429339
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Trial of Clinician-supported Patient Self-management of Hospital Insulin Therapy
- ClinicalTrials.gov ID
- NCT02144441
- Acronym / sponsor ID
- 819840
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Insulin, Self Administration, Patient Satisfaction, Glucose, Hypoglycemia, Hyperglycemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Very few patients met eligibility criteria, none of whom elected to enroll.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 May 2014 (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 will examine the feasibility of implementing a clinician-supported patient self-managed inpatient insulin intervention. It will: assess the number of eligible patients presenting over time; assess patients' willingness to enroll; assess patients' ability to successfully complete the intervention; examine occurrences of hyperglycemia and hypoglycemia; and assess patients' satisfaction with inpatient diabetes care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient self-administered insulin | Experimental | Drug: glargine and aspartThe study's only arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Admitted to the Hospital of the University of Pennsylvania (HUP) in the past 72 hours.
- Current HUP locations are Founders 12, Founders 14, Silverstein 11, and Rhoads 1.
- Age 18 years or older.
- Type-1 or type-2 diabetes mellitus requiring home basal-bolus insulin therapy administered via subcutaneous injection (not pump).
- Patient manages own basal-bolus insulin therapy at home without assistance, including measuring own blood glucose (at least at mealtimes) and administering own subcutaneous insulin.
Key exclusion criteria (15 listed)
- Inpatient order for insulin via subcutaneous infusion (i.e., pump) or intravenous infusion (i.e., drip).
- Inability to perform the activities required by the trial.
- Primary reason for admission was hyperglycemia, hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic coma, a psychiatric condition, acute alcohol poisoning, or acute drug ingestion.
- Order for a newly-prescribed or increased dose of a previously-prescribed corticosteroid.
- Enteral or parenteral nutrition.
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 |
|---|---|---|
| glargine and aspartInpatient will administer hospital-dispensed basal-bolus insulin (glargine and aspart) according to a regimen developed in collaboration with the diabetes consult service. | Drug | Patient self-administered insulin |
Primary outcome
Trial feasibility metric: number of screened patients
Time frame: 3 months
Trial feasibility metric: number of eligible patients
Time frame: 3 months
Trial feasibility metric: number of patients approached for consent
Time frame: 3 months
Trial feasibility metric: proportion of eligible patients not consenting
Time frame: 3 months
Trial feasibility metric: reasons for non-consent
Time frame: 3 months
Trial feasibility metric: characteristics of consenting subjects and non-consenting patients
Time frame: 3 months
To examine baseline demographics and clinical factors, such as: mean age, median age, proportion female sex, other demographics, proportion with type I diabetes, proportion with type II diabetes, hemoglobin A1c on admission, reasons for admission
Trial feasibility metric: proportion of enrolled subjects completing the intervention
Time frame: 3 months
Trial feasibility metric: proportion of enrolled subjects disenrolling
Time frame: 3 months
Trial feasibility metric: reasons for disenrollment
Time frame: 3 months
3 secondary outcomes
Hyperglycemia
Time frame: During hospitalization (maximum length 7 days)
Patient satisfaction
Time frame: At the end of hospitalization (maximum length 7 days)
Hypoglycemia
Time frame: During hospitalization (maximum length 7 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Derived from this study: PubMed 26429339Acton EK, Leonard CE, Schutta MH, Cardillo S, Troxel AB, Trotta R, Hennessy S. Challenges in recruiting subjects to a pilot trial of patient-managed in-hospital insulin. BMC Res Notes. 2015 Oct 1;8:523. doi: 10.1186/s13104-015-1480-6.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Sean Hennessy, PharmD, PhD principal investigator
Perelman School of Medicine at the University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glargine and aspart in people with Diabetes Mellitus, run by University of Pennsylvania 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 10 inclusion and 15 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: withdrawn, as of the sponsor's last update on 17 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Trial feasibility metric: number of screened patients (time frame: 3 months). The study lists 9 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 NCT02144441, 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 17 Mar 2015.