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Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin

Effectiveness of a Diabetes Focused Discharge Order Set Among Poorly Controlled Hospitalized Patients Transitioning to Glargine U300 Insulin

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03455985
Enrollment
158
Registered
2018-03-07
Start date
2018-05-01
Completion date
2020-09-11
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose, High, Blood Glucose, Low, Diabetes Mellitus, Type 2, Patient Discharge

Brief summary

Diabetes is present in 25% of hospitalized patients; yet effective hospital discharge programs for patients with diabetes are understudied. In particular, patients who are initiating or intensifying insulin therapy have the most to benefit in terms of glycemic control. However, these patients are also particularly vulnerable to poor transitions of care for a variety of reasons, including the complexity of therapy, inadequate patient education, differences in patient and provider expectations, and insufficient resources. Disruption of insulin therapy following hospitalization is associated with higher HbA1c, shorter survival, and increased readmissions and medical costs. In a Society of Hospital Medicine Survey, only one fourth of hospitals were supported with written protocols to standardize medication, education, equipment, and follow-up instructions. However, discharge order sets have largely been limited to the inpatient setting and have not been utilized to guide insulin use at hospital discharge. This study will assess whether a nurse supported diabetes focused inpatient discharge order set (DOS) can improve post-discharge outcomes among hospitalized patients with poorly controlled insulin-requiring diabetes.

Detailed description

In this 24 week randomized controlled trial, hospitalized insulin-requiring patients with type 2 diabetes and poor glycemic control (HbA1c \>8.5%) will receive standard of care insulin therapy including basal insulin glargine U300 (TOUJEO®) plus additional background therapy (non-insulin and prandial insulin therapies) with either a diabetes focused discharge order set (DOS) and follow-up communication to facilitate insulin titration and outpatient follow-up or enhanced standard care (ESC). 222 patients (type 2 diabetes) will be recruited. Hospitalized patients with type 2 diabetes (HbA1c \>8.5%) who are receiving basal insulin at least 10 unit per day and are able to provide informed consent and complete study procedures will be approached. All patients will be discharged on glargine U300 with initial doses determined by the discharging team. Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Patients will have follow-up phone calls at week 2, 6, and in-person visits at week 12 and 24. Phone calls will assess adherence with instructions for self-titration in the DOS group but are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. The study and all study-related documents will be approved by the OSU IRB. All data analyses will be completed as intention to treat analyses. Longitudinal outcomes (e.g., HbA1c) will be analyzed using mixed models utilizing all available measurements from individuals randomized.

Interventions

OTHERDischarge Order Set (DOS)

In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.

Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of diabetes, type 2 ≥3 months duration * HbA1c \>8.5% * Ages 25-75 years * Phone or electronic media availability * Receiving basal insulin \>10 unit/day

Exclusion criteria

* Sensitive admissions: Prisoners * Pregnancy * Unable to consent or follow study directions in English * Expected nursing facility stay longer than 2 weeks

Design outcomes

Primary

MeasureTime frameDescription
Change in HbA1c From Baseline to 24 Weeks24 weeksWe will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 24 weeks change in Hb1Ac.

Secondary

MeasureTime frameDescription
Change in HbA1c From Baseline to 12 Weeks12 weeksWe will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 12 weeks change in Hb1Ac.
Proportion Using Insulin Glargine U300 at 24 Weeks24 weeksproportion of patients who remain on insulin glargine U300 at 24 weeks The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions.
Fasting Glucose24 weeksWe will test for a difference in fasting glucose between the DOS and ESC groups using a linear mixed model. reported measure differs from original plan due to lack of fasting glucose in hospitalized patients.

Countries

United States

Participant flow

Participants by arm

ArmCount
Discharge Order Set (DOS)
Patients in the DOS group will receive instructions for self-titration of basal insulin as part of the discharge order. The DOS contains a comprehensive checklist for basic diet, hospital follow-up, glucose targets and instructions for monitoring, insulin pens and pen needles, glucose testing supplies, and ancillary orders. Phone calls will assess adherence with instructions for self-titration. Glucose lowering medication management following discharge will otherwise be conducted by the patient's usual or designated standard of care provider. Discharge Order Set (DOS): In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.
82
Enhanced Standard Care (ESC)
Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider. Enhanced Standard Care (ESC): Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
76
Total158

Baseline characteristics

CharacteristicDischarge Order Set (DOS)Enhanced Standard Care (ESC)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
10 Participants9 Participants19 Participants
Age, Categorical
Between 18 and 65 years
72 Participants67 Participants139 Participants
Age, Continuous52.0 years
STANDARD_DEVIATION 10.1
51.4 years
STANDARD_DEVIATION 10.5
51.7 years
STANDARD_DEVIATION 10.2
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants1 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
80 Participants75 Participants155 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
41 Participants41 Participants82 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
40 Participants34 Participants74 Participants
Region of Enrollment
United States
82 participants76 participants158 participants
Sex: Female, Male
Female
47 Participants43 Participants90 Participants
Sex: Female, Male
Male
35 Participants33 Participants68 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 820 / 76
other
Total, other adverse events
0 / 820 / 76
serious
Total, serious adverse events
30 / 8234 / 76

Outcome results

Primary

Change in HbA1c From Baseline to 24 Weeks

We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 24 weeks change in Hb1Ac.

Time frame: 24 weeks

Population: Data were collected at study visits and extracted from the electronic medical records.

ArmMeasureValue (MEAN)Dispersion
Discharge Order Set (DOS)Change in HbA1c From Baseline to 24 Weeks-2.1 percentage of glycosylated hemoglobinStandard Error 0.3
Enhanced Standard Care (ESC)Change in HbA1c From Baseline to 24 Weeks-1.0 percentage of glycosylated hemoglobinStandard Error 0.3
p-value: 0.09Regression, Linear
Secondary

Change in HbA1c From Baseline to 12 Weeks

We will test for a difference in 24 week change in HbA1c between the DOS and ESC groups using a linear mixed model for the longitudinal HbA1c measurements. A Wald test of the treatment-by-time interaction will be used to test our primary hypothesis that DOS affects 12 weeks change in Hb1Ac.

Time frame: 12 weeks

Population: HbA1c was obtained from study visits as well as from the electronic medical record.

ArmMeasureValue (MEAN)Dispersion
Discharge Order Set (DOS)Change in HbA1c From Baseline to 12 Weeks-2.0 percentage of glycosylated hemoglobinStandard Error 0.3
Enhanced Standard Care (ESC)Change in HbA1c From Baseline to 12 Weeks-1.4 percentage of glycosylated hemoglobinStandard Error 0.3
p-value: 0.2Regression, Linear
Secondary

Fasting Glucose

We will test for a difference in fasting glucose between the DOS and ESC groups using a linear mixed model. reported measure differs from original plan due to lack of fasting glucose in hospitalized patients.

Time frame: 24 weeks

Population: Data were collected from study visits from participants who were fasting.

ArmMeasureValue (MEDIAN)
Discharge Order Set (DOS)Fasting Glucose152.5 mg/dl
Enhanced Standard Care (ESC)Fasting Glucose209 mg/dl
p-value: 0.39Regression, Linear
Secondary

Proportion Using Insulin Glargine U300 at 24 Weeks

proportion of patients who remain on insulin glargine U300 at 24 weeks The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions.

Time frame: 24 weeks

Population: The difference in proportions of patients who remain on insulin glargine U300 at 24 weeks between treatment groups will be computed and compared using test of proportions.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Discharge Order Set (DOS)Proportion Using Insulin Glargine U300 at 24 Weeks25 Participants
Enhanced Standard Care (ESC)Proportion Using Insulin Glargine U300 at 24 Weeks25 Participants
p-value: >0.99Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026