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Insulin-treated diabetes in dependent or institutionalized patients is often poorly balanced and continuous glucose measurement is underused. The purpose of this tudy is to know how smart connected insulin pens and continuous glucose measurement can improve insulin therapy practice in dependent and/or institutionalized patients?
Insulin-treated diabetes in dependent or institutionalized patients is often poorly balanced and continuous glucose measurement is underused. Current practice and my experience in diabetes show a misuse of insulin therapy by caregivers at home and in institutions. Studies on the elderly insulin-treated person living in institutions show, through continuous glucose measurement, frequent nocturnal hypoglycemia at 79%. The continuous measurement of glucose has also shown its interest in reducing hospitalizations for acute event and, permanently.
A norwegian study shows that hypoglycemic treatments are too frequently prescribed in nursing homes. Hospitalizations for severe hypoglycemia are often due to dose errors or unsupervised recommendations in people over 65 years.
Smart connected insulin pens have shown a benefit in the management of insulin therapy in patients living with type 1 diabetes, improving glycemic balance.
Study focuses on the identification of misuses of insulin therapy in dependent and/or institutionalized patients. A study of everyday life, we expect a decrease in dysfunctions in patients equipped with a continuous glucose measurement system and connected pens after advice given to their caregivers.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling home caregivers | Behavioral | Advice on the proper use of insulin therapy will be given, if necessary, to caregivers. Patients are reviewed at 1 month of this first visit with a collection of the same data |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Injection | Percentage of insulin injections not as prescribed | at day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| number of missed injections | Percentage of missed injections | at day 0 |
| number of injections | Percentage of injections performed with a dose deviation of +-20% from the prescribed dose |
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Inclusion Criteria:
Exclusion Criteria:
- Patient refusing study.
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patient managed by a caregivers for the management of insulin therapy at home or in nursing home or in healthcare facility.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie BOULY, APN | Contact | 01 61 69 35 93 | marie.bouly@chsf.fr | |
| Caroline TOURTE | Contact | 01 61 69 31 50 | caroline.tourte@chsf.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie BOULY, APN | Centre Hospitalier Sud Francilien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Recruiting | Corbeil-Essonnes | France | 91106 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34324624 | Background | Bouillet B, Tscherter P, Vaillard L, Nonciaux C, Hourdain P, Ravier A, Rouland A, Petit JM, Verges B, Quilot E. Frequent and severe hypoglycaemia detected with continuous glucose monitoring in older institutionalised patients with diabetes. Age Ageing. 2021 Nov 10;50(6):2088-2093. doi: 10.1093/ageing/afab128. | |
| 36094418 | Background |
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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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| at day 0 |
| number of injections | Percentage of injections performed outside the meal time : more than 15 minutes before or more than an hour after the meal. | at day 0 |
| Continuous glucose measurement parameters | Time in range | at day 0 |
| Continuous glucose measurement parameters | Time in range | at day 30 |
| Acute Diabetes Events | severe hypoglycemia, hyperglycemia requiring hospitalization | at day 0 |
| Acute Diabetes Events | severe hypoglycemia, hyperglycemia requiring hospitalization | at day 30 |
| Guerci B, Roussel R, Levrat-Guillen F, Detournay B, Vicaut E, De Pouvourville G, Emery C, Riveline JP. Important Decrease in Hospitalizations for Acute Diabetes Events Following FreeStyle Libre System Initiation in People with Type 2 Diabetes on Basal Insulin Therapy in France. Diabetes Technol Ther. 2023 Jan;25(1):20-30. doi: 10.1089/dia.2022.0271. Epub 2022 Nov 24. |
| 35604792 | Background | Riveline JP, Roussel R, Vicaut E, de Pouvourville G, Detournay B, Emery C, Levrat-Guillen F, Guerci B. Reduced Rate of Acute Diabetes Events with Flash Glucose Monitoring Is Sustained for 2 Years After Initiation: Extended Outcomes from the RELIEF Study. Diabetes Technol Ther. 2022 Sep;24(9):611-618. doi: 10.1089/dia.2022.0085. Epub 2022 Jul 11. |
| 24853809 | Background | Andreassen LM, Sandberg S, Kristensen GB, Solvik UO, Kjome RL. Nursing home patients with diabetes: prevalence, drug treatment and glycemic control. Diabetes Res Clin Pract. 2014 Jul;105(1):102-9. doi: 10.1016/j.diabres.2014.04.012. Epub 2014 Apr 28. |
| 34738244 | Background | Poret F, Nacher M, Pujo J, Cauvin JM, Demar M, Massicard M, Sabbah N. Risk factors for hypoglycaemia in people with diabetes admitted to the Emergency Department of a Hospital in French Guiana. Diabet Med. 2022 Feb;39(2):e14736. doi: 10.1111/dme.14736. Epub 2021 Nov 23. |
| 35775735 | Background | Ekberg NR, Hartvig NV, Kaas A, Moller JB, Adolfsson P. Smart Pen Exposes Missed Basal Insulin Injections and Reveals the Impact on Glycemic Control in Adults With Type 1 Diabetes. J Diabetes Sci Technol. 2024 Jan;18(1):66-73. doi: 10.1177/19322968221104142. Epub 2022 Jul 1. |
| 32003590 | Background | Adolfsson P, Hartvig NV, Kaas A, Moller JB, Hellman J. Increased Time in Range and Fewer Missed Bolus Injections After Introduction of a Smart Connected Insulin Pen. Diabetes Technol Ther. 2020 Oct;22(10):709-718. doi: 10.1089/dia.2019.0411. Epub 2020 Mar 11. |