Diabetes
Conditions
Keywords
Diabetes
Brief summary
In this study the investigators would like to test the hypothesis that in diabetic patients discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected Glargine in terms of diabetes control, compliance, and patient satisfaction and preference. The investigators will test this hypothesis in a randomized, crossover trial.
Interventions
DRUGGlargine insulin
20-180 units per day
Sponsors
Sanofi
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* All patients with type 1 and 2 diabetes discharged from the hospital with recommendations to take Glargine
Exclusion criteria
* Patients unwilling to participate and patients incapable of complying with the study regimen, such as patients with alcohol and drug addiction problems and patients with severe mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c at Three Months of Each Period of Treatment | Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2) | Data was collected by group |
Secondary
| Measure | Time frame |
|---|---|
| Compliance and Patient Satisfaction | 6 months of treatment after discharge from the hospital |
Countries
United States
Participant flow
Pre-assignment details
Although this is a crossover study, no information is available on the participants that completed phase 1 and started phase 2, and so these milestones are not included. Multiple attempts were made to obtain this information, however the PI is retired and data could not be obtained from any remaining personnel associated with the study. The number of participants started and completed reflects the participants confirmed to have started and completed the study. 43 participants were consented.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Pen-administered, then syringe-admnistered Glargine Group (1) AND Syringe-administered then pen-administered Glargine Group (2)
Group 1: SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin Glargine insulin: 20-180 units per day
Group 2: Syringe-administered Glargine insulin and then pen-administered Glargine insulin Glargine insulin: 20-180 units per day | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized Age 22-70 | 43 Participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
Primary
HbA1c at Three Months of Each Period of Treatment
Data was collected by group
Time frame: Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2)
Population: The only outcome measure available for this measurement is by group. This measure cannot be entered by intervention (e.g. Arm 1: Pen, Arm 2: Syringe). Multiple attempts were made to obtain this information, however the PI is retired and data could not be obtained from any remaining personnel associated with the study. Participants that did not complete the study are not included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Pen-administered, Then Syringe-admnistered Glargine | HbA1c at Three Months of Each Period of Treatment | HbA1C at 3 months (end of intervention 1, before crossover) | 7.8 percentage (DCCT unit) | Standard Deviation 1.7 |
| Group 1: Pen-administered, Then Syringe-admnistered Glargine | HbA1c at Three Months of Each Period of Treatment | HbA1c at 6 Months (end of dose 2, after crossover) | 8.5 percentage (DCCT unit) | Standard Deviation 2 |
| Group 1: Pen-administered, Then Syringe-admnistered Glargine | HbA1c at Three Months of Each Period of Treatment | Baseline HbA1c | 10.7 percentage (DCCT unit) | Standard Deviation 2.2 |
| Group 2: Syringe-administered Then Pen-administered Glargine | HbA1c at Three Months of Each Period of Treatment | Baseline HbA1c | 11.2 percentage (DCCT unit) | Standard Deviation 2.5 |
| Group 2: Syringe-administered Then Pen-administered Glargine | HbA1c at Three Months of Each Period of Treatment | HbA1C at 3 months (end of intervention 1, before crossover) | 7.3 percentage (DCCT unit) | Standard Deviation 1.4 |
| Group 2: Syringe-administered Then Pen-administered Glargine | HbA1c at Three Months of Each Period of Treatment | HbA1c at 6 Months (end of dose 2, after crossover) | 7.1 percentage (DCCT unit) | Standard Deviation 1.6 |
Secondary
Compliance and Patient Satisfaction
Time frame: 6 months of treatment after discharge from the hospital
Population: No data is available for this outcome measure. Multiple attempts were made to obtain this information, however the PI is retired and data could not be obtained from any remaining personnel associated with the study.