Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glargine | Experimental | We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glargine | Drug | Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Duration of Hypoglycemia Episodes | duration of hypoglycemia measured by continuous glucose monitoring | 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 | baseline, 5 months, 8 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medha N Munshi, MD | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16936162 | Background | Narayan KM, Boyle JP, Geiss LS, Saaddine JB, Thompson TJ. Impact of recent increase in incidence on future diabetes burden: U.S., 2005-2050. Diabetes Care. 2006 Sep;29(9):2114-6. doi: 10.2337/dc06-1136. No abstract available. | |
| 9539999 | Background | Economic consequences of diabetes mellitus in the U.S. in 1997. American Diabetes Association. Diabetes Care. 1998 Feb;21(2):296-309. doi: 10.2337/diacare.21.2.296. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Duration of Hypoglycemia Episodes | duration of hypoglycemia measured by continuous glucose monitoring | Subject drop outs | Posted | Mean | Standard Deviation | minutes of hypoglycemia | baseline, 5 months, 8 months |
|
|
Adverse Event data was collected during the 8 month time period that the participants were in the trail.
Participants were contacted ona weekly or bi-weekly basis to discuss blood glucose readings and an other issues that they had been having.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Subject passed away from unknown causes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prednisone Taper Needed | General disorders | Non-systematic Assessment | Subjects paused their time in the study due to the use of prednisone, unrelated to study intervention. Prednisone affected blood glucose readings during this time. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medha Munshi, MD | Joslin Diabetes Center | 617-309-4683 | medha.munshi@joslin.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 15177276 | Background | Bertoni AG, Kirk JK, Goff DC Jr, Wagenknecht LE. Excess mortality related to diabetes mellitus in elderly Medicare beneficiaries. Ann Epidemiol. 2004 May;14(5):362-7. doi: 10.1016/j.annepidem.2003.09.004. |
| 12757559 | Background | Blaum CS, Ofstedal MB, Langa KM, Wray LA. Functional status and health outcomes in older americans with diabetes mellitus. J Am Geriatr Soc. 2003 Jun;51(6):745-53. doi: 10.1046/j.1365-2389.2003.51256.x. |
| Background | Bonsignore P DL, Suhl E, Sternthal A, Giusti J, Munshi MN. Unrecognized Errors in Insulin Injection Techniques Are Frequent in Older Adults Even with Longer Duration of Insulin Use. In: American Diabetes Association annual meeting 2009; 2009; New Orleans LA; 2009. p. 913-P. |
| Background | Medha N. Munshi EB, Ramachandiran Cooppan. Diabetes in the Older Adult. In: Richard S. Beaser MatSoJDC, ed. Joslin's Diabetes Deskbook : A guide for primary care providers. 2nd ed. Boston: Joslin Diabetes Center; 2007:623-38. |
| 9250229 | Background | Shorr RI, Ray WA, Daugherty JR, Griffin MR. Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med. 1997 Aug 11-25;157(15):1681-6. |
| Background | McAulay V FB. Hypoglycemia in diabetes in old age. In: Sinclair A, Finucane P, ed. 2nd ed. Chichester, UK: John wiley and sons; 2001:133-52. |
| 12716809 | Background | Desouza C, Salazar H, Cheong B, Murgo J, Fonseca V. Association of hypoglycemia and cardiac ischemia: a study based on continuous monitoring. Diabetes Care. 2003 May;26(5):1485-9. doi: 10.2337/diacare.26.5.1485. |
| 12166599 | Background | Frier BM. Hypoglycaemic valleys: an under-recognised problem in type 2 diabetes? Int J Clin Pract Suppl. 2002 Jul;(129):12-9. |
| 16306561 | Background | Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care. 2005 Dec;28(12):2948-61. doi: 10.2337/diacare.28.12.2948. No abstract available. |
| Background | Ayres D SE, Capelson R, Weinger K, Munshi M. Identifying Barriers to Diabetes Education and Self-Care in Older Adults. In: American diabetes Association 65th scientific sessions 2005; San Diego CA; 2005. p. 941-P |
| 16873782 | Background | Munshi M, Grande L, Hayes M, Ayres D, Suhl E, Capelson R, Lin S, Milberg W, Weinger K. Cognitive dysfunction is associated with poor diabetes control in older adults. Diabetes Care. 2006 Aug;29(8):1794-9. doi: 10.2337/dc06-0506. |
| Background | Munshi MN DL, Iwata I, Suhl E, Giusti J, Bonsignore P, Sternthal A The Risk of Hypoglycemia Is a Treatment-Limiting Factor in Older Adults Even with Poor Glycemic Control. In: American Diabetes Association annual meeting 2009; 2009; New Orleans LA; 2009. p. 2123-PO. |
| 19332236 | Background | Munshi MN, Hayes M, Sternthal A, Ayres D. Use of serum c-peptide level to simplify diabetes treatment regimens in older adults. Am J Med. 2009 Apr;122(4):395-7. doi: 10.1016/j.amjmed.2008.12.008. |
| 16386091 | Background | Kovatchev BP, Clarke WL, Breton M, Brayman K, McCall A. Quantifying temporal glucose variability in diabetes via continuous glucose monitoring: mathematical methods and clinical application. Diabetes Technol Ther. 2005 Dec;7(6):849-62. doi: 10.1089/dia.2005.7.849. |
| 338408 | Background | Hendriksen C, Faber OK, Drejer J, Binder C. Prevalence of residual B-cell function in insulin-treated diabetics evaluated by the plasma C-etide response to intravenous glucagon. Diabetologia. 1977 Dec;13(6):615-9. doi: 10.1007/BF01236316. |
| 326604 | Background | Faber OK, Binder C. C-peptide response to glucagon. A test for the residual beta-cell function in diabetes mellitus. Diabetes. 1977 Jul;26(7):605-10. doi: 10.2337/diab.26.7.605. |
| 8805091 | Background | Montorio I, Izal M. The Geriatric Depression Scale: a review of its development and utility. Int Psychogeriatr. 1996 Spring;8(1):103-12. doi: 10.1017/s1041610296002505. |
| 10923061 | Background | Arbuthnott K, Frank J. Trail making test, part B as a measure of executive control: validation using a set-switching paradigm. J Clin Exp Neuropsychol. 2000 Aug;22(4):518-28. doi: 10.1076/1380-3395(200008)22:4;1-0;FT518. |
| 12519323 | Background | Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. Diabet Med. 2003 Jan;20(1):69-72. doi: 10.1046/j.1464-5491.2003.00832.x. |
| 7555499 | Background | Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754. |
| 8026281 | Background | Jacobson AM, de Groot M, Samson JA. The evaluation of two measures of quality of life in patients with type I and type II diabetes. Diabetes Care. 1994 Apr;17(4):267-74. doi: 10.2337/diacare.17.4.267. |
| 15920050 | Background | Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52. doi: 10.2337/diacare.28.6.1346. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | Subject drop outs | Posted | Mean | Standard Deviation | episodes of hypoglycemia | baseline, 5 months, 8 months |
|
|
|
| 3 |
| 65 |
| 18 |
| 65 |
| 4 |
| 65 |
|
| Bowel Obstruction | Gastrointestinal disorders | Non-systematic Assessment | Subject hospitalized for bowel obstruction. |
|
| hysterectomy | Reproductive system and breast disorders | Non-systematic Assessment | subject hospitalized for hysterectomy |
|
| Stroke | Vascular disorders | Non-systematic Assessment | 2 subjects had strokes and subsequent hospitalization, unrelated to study intervention. |
|
| Hospitalization for gout | General disorders | Non-systematic Assessment | subject hospitalized for gout flare up, unrelated to study intervention. |
|
| Cardiac stent placed | Cardiac disorders | Non-systematic Assessment | Subject hospitalized for cardiac stent placement. Unrelated to study intervention. |
|
| Hospitalization for internal bleeding | General disorders | Non-systematic Assessment | Subject hospitalized due to internal bleeding from mediation unrelated to study intervention. |
|
| Hospitalization for Cellulitis | Infections and infestations | Non-systematic Assessment | subject hospitalized for cellulitis unrelated to study intervention. |
|
| Hospitalization due to fall | General disorders | Non-systematic Assessment | Subject tripped and fell, resulting in hospitalization. Unrelated to study procedures. |
|
| Hospitalization for Acute renal failure | Renal and urinary disorders | Non-systematic Assessment | hospitalization for acute on chronic renal failure, thought to be interstitial nephritis. Unrelated to study intervention |
|
|
Not provided
Not provided
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|