A Phase 4 interventional study of Glargine in Diabetes, sponsored by Joslin Diabetes Center. Completed at 1 site in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2017-11-08.
Sponsored by Joslin Diabetes Center · Phase 4, Interventional, and Treatment
The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.
As patients with diabetes age, adverse social and medical problems may arise. Because of these problems patients, even those managing their diabetes for many years, find it difficult to continue with complicated insulin schedules. This may lead to errors in treatment and poor glucose control. Simplification of treatment has been found to the decrease risk of low blood glucose, a very dangerous condition at this age. In a previous study, the investigators found that simplifying treatment did not cause the blood sugars to rise out of control. In this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and A1C (measure of average glucose control over 3 months). The investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.
Joslin Diabetes Center is the lead sponsor of 79 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.
Drug: Glargine
Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
Also known as: Lantus
Change in Duration of Hypoglycemia Episodes
duration of hypoglycemia measured by continuous glucose monitoring
Time frame: baseline, 5 months, 8 months
Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months
frequency of hypoglycemia episodes measured by continuous glucose monitoring per 5 days of continuous glucose monitoring data
Time frame: baseline, 5 months, 8 months
| Milestone | Glargine |
|---|---|
| Started | 65 |
| Completed | 60 |
| Not completed | 5 |
duration of hypoglycemia measured by continuous glucose monitoring
| minutes of hypoglycemia | Glargine |
|---|---|
| Baseline | 277 ± 252 |
| 5 months | 111 ± 184 |
| 8 months | 97 ± 163 |
frequency of hypoglycemia episodes measured by continuous glucose monitoring per 5 days of continuous glucose monitoring data
| episodes of hypoglycemia | Glargine |
|---|---|
| Baseline | 4.3 ± 3.0 |
| 5 months | 1.8 ± 2.0 |
| 8 months | 1.5 ± 2.0 |
Collected over Adverse Event data was collected during the 8 month time period that the participants were in the trail.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glargine | 3/65 (4.6%) | 18/65 (27.7%) | 4/65 (6.2%) |
| Event | Glargine |
|---|---|
| DeathGeneral disorders | 3/65 |
| StrokeVascular disorders | 3/65 |
| Cardiac stent placedCardiac disorders | 3/65 |
| Hospitalization for internal bleedingGeneral disorders | 2/65 |
| Hospitalization for Acute renal failureRenal and urinary disorders | 2/65 |
| Bowel ObstructionGastrointestinal disorders | 1/65 |
| hysterectomyReproductive system and breast disorders | 1/65 |
| Hospitalization for goutGeneral disorders | 1/65 |
| Hospitalization for CellulitisInfections and infestations | 1/65 |
| Hospitalization due to fallGeneral disorders | 1/65 |
| Event | Glargine |
|---|---|
| Prednisone Taper NeededGeneral disorders | 4/65 |
| Age, Categorical(Participants) | Glargine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 65 |
| Sex: Female, Male(Participants) | Glargine |
|---|---|
| Female | 32 |
| Male | 33 |
| Race (NIH/OMB)(Participants) | Glargine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 11 |
| White | 54 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Glargine |
|---|---|
| United States | 65 |
Plan to share: Undecided
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Joslin Diabetes Center