Marianna Yaron1,2,3, Bruria Sher4, Daniel Sorek4, Mina Shomer4, Noa Levek4, Tali Schiller4, Monica Gaspar4, Rachel Frumkin Ben-David4, Kineret Mazor-Aronovitch4,5,6, Efrat Tish4, Yoni Shapira4,7,5, Orit Pinhas-Hamiel4,5,6. 1. Maccabi National Juvenile Diabetes Center, Raanana, Israel. mariannayaron@gmail.com. 2. Institute of Endocrinology, Metabolism and Hypertension, Tel-Aviv Sourasky Medical Center, 6 Weizmann Street, 64239, Tel Aviv, Israel. mariannayaron@gmail.com. 3. Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. mariannayaron@gmail.com. 4. Maccabi National Juvenile Diabetes Center, Raanana, Israel. 5. Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. 6. Pediatric Endocrine and Diabetes Unit, Sheba Medical Center, Edmond and Lily Safra Children's Hospital, Ramat-Gan, Israel. 7. Institute of Endocrinology, Metabolism and Hypertension, Tel-Aviv Sourasky Medical Center, 6 Weizmann Street, 64239, Tel Aviv, Israel.
Abstract
AIM: To examine the effectiveness and safety over a 12-month period of a telemedicine intervention in adults with type 1 diabetes (T1D) treated with insulin pumps. METHODS:74 T1D patients on insulin pumps for at least 1 year (mean 19.5 [11.5] years) and HbA1c ≥ 6.5% (≥ 48 mmol/mol) were randomized to the telemedicine (n = 37) or the standard care group (n = 37). The intervention group was instructed to download data from insulin pumps and glucometers monthly. They received immediate phone feedback and recommendations for insulin dose adjustment; and face-to-face visits once in 6 months, compared to once every 3 months for the standard care group. Satisfaction with treatment, quality of life and frequency of hypoglycemic events was evaluated. RESULTS: The mean changes in HbA1c adjusted to baseline were - 0.08% (0.25 mmol/mol) vs. - 0.01% (0.03 mmol/mol), in the intervention and control groups, respectively (p = 0.18) at 12 months, without an increased frequency of hypoglycemia. Patients in the intervention group felt satisfied and interested in continuing with the treatment (p = 0.04). The quality of life scores were similar in both groups. Direct total costs were 24% less in the intervention group, and indirect total costs decreased by 22% compared to the year preceding the study. CONCLUSIONS: Internet-based insulin dose adjustment is as effective and safe as routine care in adults with type 1 diabetes treated by insulin pumps. For suitable patients, some of the time-consuming routine visits may be replaced by user-friendly digital medicine. CLINICAL TRIAL REGISTRATION: Clinical Trial.gov Identifier NCT01887431.
RCT Entities:
AIM: To examine the effectiveness and safety over a 12-month period of a telemedicine intervention in adults with type 1 diabetes (T1D) treated with insulin pumps. METHODS: 74 T1D patients on insulin pumps for at least 1 year (mean 19.5 [11.5] years) and HbA1c ≥ 6.5% (≥ 48 mmol/mol) were randomized to the telemedicine (n = 37) or the standard care group (n = 37). The intervention group was instructed to download data from insulin pumps and glucometers monthly. They received immediate phone feedback and recommendations for insulin dose adjustment; and face-to-face visits once in 6 months, compared to once every 3 months for the standard care group. Satisfaction with treatment, quality of life and frequency of hypoglycemic events was evaluated. RESULTS: The mean changes in HbA1c adjusted to baseline were - 0.08% (0.25 mmol/mol) vs. - 0.01% (0.03 mmol/mol), in the intervention and control groups, respectively (p = 0.18) at 12 months, without an increased frequency of hypoglycemia. Patients in the intervention group felt satisfied and interested in continuing with the treatment (p = 0.04). The quality of life scores were similar in both groups. Direct total costs were 24% less in the intervention group, and indirect total costs decreased by 22% compared to the year preceding the study. CONCLUSIONS: Internet-based insulin dose adjustment is as effective and safe as routine care in adults with type 1 diabetes treated by insulin pumps. For suitable patients, some of the time-consuming routine visits may be replaced by user-friendly digital medicine. CLINICAL TRIAL REGISTRATION: Clinical Trial.gov Identifier NCT01887431.
Entities:
Keywords:
Internet-based therapeutic intervention; Telemedicine; Type 1 diabetes mellitus; Young adults
Authors: Anders Nikolai Ørsted Schultz; Robin Christensen; Georg Bollig; Kristian Kidholm; F Brandt Journal: BMJ Open Date: 2022-04-27 Impact factor: 3.006