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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01765-42 | Other Identifier | ANSM |
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Basal insulin is widely used in older patients with diabetes. Human insulin Neutral Protamine Hagedorn (NPH) has been proposed as basal insulin in older (75 years or older) frail and dependent patients due to its shorter action. However, no study has analysed the glycaemic profile in elderly subjects according to the basal insulin used, particularly in frail or disabled patients.
The aim of this study is to measure intra-day glycaemic variability according basal insulin (human NPH or long acting analogues) in older (75 and older) frail or disabled patients with diabetes using continuous glucose monitoring system.
Increased prevalence of diabetes mellitus is in large part related to ageing: in France in 2009, 26% of patients with diabetes were 75 older or over. Moreover, diabetes prevalence is particularly high among institutionalized subjects with more than half of them treated with insulin.
Diabetes is source of activities limitations and participation restriction from the early stages of the disease and is responsible for 10% of direct health costs, with higher costs for older patients or insulin treated patients.
Older patients with diabetes may be robust (fully independent), frail or disabled. Studies with patients of 75 years or older included mainly robust subjects. Nevertheless older patients with diabetes are more frequently frail and a large proportion have a different metabolic profile than younger ones: they are leaner and present more often with beta-cellular insufficiency. Frail or dependent patients may also have different nutritional status than robust ones. Thus, this is difficult to extrapolate what is known about glycaemic profile in robust and young older (65-74 years old) insulin-treated patients to frail and dependent older ones (>74 years).
Continuous blood glucose monitoring systems give the opportunity to measure around the day the blood glucose variations in real-life and particularly nocturnal hypoglycaemia for these patients treated with various types of basal insulins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Neutral Protamine Hagedorn (NPH) | Experimental | The inclusion will be stratified into 2 groups according to the type of basal insulin being at baseline (ratio 1: 1): NPH human insulin / Long-acting basal insulin analogues. The type of insulin will not be changed by this protocol. |
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| Long-acting basal insulin analogues | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Continuous glucose monitoring system over 120-hour period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Intraday glycemic variability measured by the average of MAGE index (Mean amplitude of glycemic excursions) everyday of exploitable recording by the participant. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intraday glycemic variability measured by the average standard deviation of blood glucose every day of exploitable recording by the participant | 5 days | |
| Inter-day glucose variability assessed by Mean Differences of Daily per participant for every day of exploitable recording |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie DANET-LAMASOU, Dr | Universitary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Bordeaux - Xavier Arnozan Hospital | Pessac | 33600 | France |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| 5 days |
| Average number of diurnal hypoglycaemia defined by blood glucose <0.60g / l from 7am to 22 pm for all exploitable recording days | 5 days |
| Average number of nocturnal hypoglycemia, defined by blood glucose < 0.60g / l between 22h and 7h for every day of exploitable recording | 5 days |
| Average time (minutes / day) per day pass in hypoglycemia (<0.60g / l) | 5 days |
| Nutritional status: a composite outcome measure consisting of multiple measures with Mini Nutritional Assessment, calf circumference, abdominal circumference, albumin | At inclusion |
| Functional Status: a composite outcome measure consisting of multiple measures with scale Rosow and Breslau, Lawton Instrumental Activities of Daily Living Scale, score of Barthel for Activities of Daily Living score evaluation and SPPB Scale | At inclusion |
| Evaluation of Cognition with Mini Mental Status Examination (MMSE) | At inclusion |
| Fragility level (Rockwood criteria) | At inclusion |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |