Diabetes
Conditions
Keywords
simplification, glargine, elderly
Brief summary
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.
Detailed description
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.
Interventions
DRUGGlargine
Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
Sponsors
Sanofi
Joslin Diabetes Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 70 years or older * Diagnosis of diabetes mellitus Type II * At least 2 (short-acting or mixed) insulin injections per day * At least 1 episode of hypoglycemia (glucose value \<70) on screening CGM
Exclusion criteria
* Patients with the following illnesses in the past 12 months Myocardial infarction Angina Coronary artery bypass grafting Percutaneous transluminal coronary angiography Cerebrovascular event (stroke, TIA) * Active liver disease (history of cirrhosis or LFT \> 3 times normal) * On dialysis or with severe renal dysfunction (creatinine clearance \<20 ml/min) * Malignancy that limits life span to less than 18 months * Patients seen in the geriatric clinic who already have simplified regimen as proposed in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Duration of Hypoglycemia Episodes | baseline, 5 months, 8 months | duration of hypoglycemia measured by continuous glucose monitoring |
| Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months | baseline, 5 months, 8 months | frequency of hypoglycemia episodes measured by continuous glucose monitoring per 5 days of continuous glucose monitoring data |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Glargine We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.
Glargine: Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Glargine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 65 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 54 Participants |
| Region of Enrollment United States | 65 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 65 |
| other Total, other adverse events | 4 / 65 |
| serious Total, serious adverse events | 18 / 65 |
Outcome results
Primary
Change in Duration of Hypoglycemia Episodes
duration of hypoglycemia measured by continuous glucose monitoring
Time frame: baseline, 5 months, 8 months
Population: Subject drop outs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glargine | Change in Duration of Hypoglycemia Episodes | Baseline | 277 minutes of hypoglycemia | Standard Deviation 252 |
| Glargine | Change in Duration of Hypoglycemia Episodes | 5 months | 111 minutes of hypoglycemia | Standard Deviation 184 |
| Glargine | Change in Duration of Hypoglycemia Episodes | 8 months | 97 minutes of hypoglycemia | Standard Deviation 163 |
Primary
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
Population: Subject drop outs
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glargine | Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months | 5 months | 1.8 episodes of hypoglycemia | Standard Deviation 2 |
| Glargine | Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months | Baseline | 4.3 episodes of hypoglycemia | Standard Deviation 3 |
| Glargine | Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months | 8 months | 1.5 episodes of hypoglycemia | Standard Deviation 2 |