| Simell et al, Finland (1991)1111. Simell T, Kaprio EA, Maenpaa J, Tuominen J, Simell O. Randomised prospective study of short-term and long-term initial stay in hospital by children with diabetes mellitus. The Lancet. 1991; 337(8742):656-60. |
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To report the effects on metabolic control of an educational intervention developed during hospitalization.
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RCT.
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61 children and adolescents, 0 to 14 years, newly diagnosed with T1D.
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Theme: intensive use of insulin
Group 1 (G1): daily educational program from the 2nd to the 7th day of hospitalization. Outpatient follow-up for three weeks, with 3-4 visits. Group 2 (G2): educational program started on the 7th day of hospitalization, continued two times a week until discharge in the 4th week. Professionals involved: pediatrician, dietician, social worker, psychologist, hospital nurse with diabetes training and nurse from the outpatient clinic specialized in diabetes. Both groups: availability of telephone appointments with a senior pediatrician during the two years of the study. Monthly and quarterly follow-up. After two years, the participants were evaluated for two days, looking at the circadian variation in diabetes control and endogenous insulin secretion. |
Clinical outcomes only:
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HbA1c: improvement after one month in G1 (p=.01). After two months, both groups reached mean values comparable to healthy individuals. In two years, there was an increase in HbA1c from 7.4% at 3 months to 9% in the 21st month of treatment in G1; increase from 7.8% to 8.8% at 18 months in G2. Significant correlation between the time of diagnosis of the disease and increase in HbA1c (p=.004), constant in the two years of study.
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C peptide: undetectable after 6 months in G1 and after 12 months in G2, occurring first in children aged 7 to 10 years and, last, in adolescents. There was no correlation between HbA1c and C peptide after two years of study.
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Insulin use: lower mean for G1 in the two years of study. Changes related to the time of diagnosis and not to the period of hospitalization.
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| Grey et al, United States (1998)*,1212. Grey M, Boland EA, Davidson M, Yu C, Sullivan-Bolyai SS, Tamborlane WV. Short-term effects of coping skills training as adjunct to intensive therapy in adolescents. Diabetes Care. 1998; 21(6):902-8. |
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To determine whether Coping Skills Training (CST) combined with intensive diabetes treatment improves metabolic control (MC) and quality of life (QoL) of adolescents starting intensive therapy regimens.
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RCT.
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65 adolescents, 13 to 18 years old, on insulin therapy for at least one year.
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Theme: coping skills in the management of intensive insulin therapy.
Control group (CG): intensive treatment (multiple-dose insulin therapy). Experimental group (EG): intensive treatment and CST, which consisted of dramatization of everyday situations (food choices, conflicts, decision making), to train coping skills. Participants were evaluated and the scene was repeated until the expected behavior was identified. Groups of 2-3 adolescents; average duration 1-1.5 hours. The adolescents participated in an average of six weekly sessions, followed by monthly consultations at the pediatric diabetes clinic for three months. |
Clinical:
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decrease in HbA1c after three months, faster and greater one month after the start of intensive treatment, maintained until the end of the study in the EG.
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In both groups, intensive therapy associated with a higher number of monthly visits led to a decrease in HbA1c at three months (p<.01).
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The results suggest that intensive treatment improves MC, which can be intensified through the CST.
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CST has an immediate beneficial effect on the adolescent's ability to obtain MC in the short term.
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There was no difference between the groups in terms of insulin doses or number of blood glucose monitoring checks performed per day.
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The intervention did not affect the decrease in acute complications.
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BMI increased in the overweight participants in both groups.
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Behavioral: improved self-efficacy (Self-Efficacy for Diabetes scale), depression (Children’s Depression Inventory), QoL (Diabetes Quality of Life Youth scale), and coping with T1D (Issues in coping with IDDM) during the three months of study in EG. |
| Grey et al, United States (2000)*1313. Grey M, Boland EA, Davidson M, Li J, Tamborlane WV. Coping skills training for youth with diabetes mellitus has long-lasting effects on metabolic control and quality of life. J Pediatr. 2000 Jul;137(1):107-13. |
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To determine if the initial effect of CST on MC and QoL, combined with intensive care, can be maintained in young people who are starting treatment.
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RCT.
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77 adolescents, 12 to 17 years old, on insulin therapy for at least one year.
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Theme: coping skills in the management of intensive insulin therapy.
Control group (CG): intensive treatment (multiple-dose insulin therapy). Experimental group (EG): intensive treatment and CST, which consisted of dramatization of everyday situations to train coping skills. Participants were evaluated and the scene was repeated until the expected behavior was identified. Groups of 2-3 adolescents: average duration of 1-1.5 hours. The adolescents participated in an average of six weekly sessions, followed by monthly appointments at the Pediatric Diabetes Clinic for 12 months. |
Clinical:
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decrease in HbA1c after 12 months in EG.
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Better MC in EG with better self-efficacy related to diabetes and medical treatment (Self-Efficacy for Diabetes scale), with statistical significance during the six months.
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Behavioral: less negative impact on QoL (Diabetes Quality of Life Youth scale) after 12 months, with the best results observed in the first three months of intervention. |
Howells et al, Scotland (2002)1414. Howells L, Wilson TC, Skinner R, Newtont AD, Morrist D, Greene SA. A randomized control trial of the effect of negotiated telephone support on glycaemic control in young people with Type 1 diabetes. Diabetic Med [Internet]. 2002 [cited 2018 Sept 18];19:643-8. Available from: https://doi.org/10.1046/j.1464-5491.2002.00791.x
https://doi.org/10.1046/j.1464-5491.2002...
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To evaluate the changes in self-efficacy of young people with T1D who participated in the Negotiated Telephone Support (NTS) intervention.
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RCT.
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79 young people, 12 to 24 years old, on conventional insulin therapy.
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Theme: problem-solving concerning T1D.
Group 1 (G1): conventional treatment (quarterly consultation at the diabetes center). Group 2 (G2): conventional treatment and NTS, consisting of a phone call by a dietician specialized in pediatrics and diabetes over a one-year period. Adolescents decided on the theme of the call, which took place every two to three weeks, with the option of extra calls upon the youth's initiative. Home visits by one clinical psychologist for active instruction and delivery of a leaflet on problem-solving. Group 3 (G3): NTS and consultation at the diabetes center once/year, HbA1c every three months (at home or collection at the center). Most chosen themes in NTS: diabetes (general), performance at work, friendship, relationship with parents and siblings, health, social life and leisure, school/university, and others. On average, each participant received 16 calls, lasting nine minutes each, at three-week intervals. |
Clinical:
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the NTS did not improve glycemic control in G2 and G3.
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G1, G2 and G3 showed an increase in BMI during the study.
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There was a statistically significant correlation (p<.01) between the participant's age and the average duration of the telephone contact in G2 and G3.
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Fewer consultations at the diabetes center in G3.
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G1, G2, and G3 showed no statistically significant differences (p=.84) in the number of emergency hospitalizations due to diabetes complications during the study.
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Behavioral: there was no statistically significant difference between the groups in the self-efficacy scores (Self-Efficacy for Diabetes), treatment adherence barriers (Environmental barriers to Adherence Questionnaire) problem solving (Social Problem Solving Inventory), and diabetes knowledge (Diabetes Knowledge Scale). Self-efficacy increased significantly in the combined intervention and in individuals with HbA1c under 8%. |
Lawson et al, Canada (2005)1515. Lawson M, Cohen N, Richardson C, Orrbine E, Pham B. A randomized trial of regular standardized telephone contact by a diabetes nurse educator in adolescents with poor diabetes control. Ped Diabet [Internet]. 2005 [cited 2018 Sept 18];6:2-40. Available from: https://doi.org/10.1111/j.1399-543X.2005.00091.x
https://doi.org/10.1111/j.1399-543X.2005...
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To determine the effect of telephone contact on MC, treatment compliance, and QoL of adolescents with T1D.
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RCT.
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43 adolescents, 13 to 17 years old. T1D for at least 1 year, insulin therapy 2-3 times/day and inappropriate glycemic control in the last 6 months.
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Theme: adjustments to insulin dosages.
Control group (CG): standard care (two or three doses of NPH and regular insulin, or glycemic corrections with ultrafast insulin; meal plan with a dietician once per year; quarterly medical return with diabetologist and HbA1c). Experimental group (EG): standard care and telephone contact for six months. Two diabetes nurse educators each contacted about 11-12 adolescents weekly, to discuss the blood glucose diary of the previous week and necessary adjustments in insulin dosages. |
Clinical:
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decrease in HbA1c in 29% of participants in EG and increase in 19% (p=.015) of the participants in EG. Increased HbA1c in CG.
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Increased BMI in EG.
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There were no changes in insulin dosages or severe hypoglycemic episodes in both groups.
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Behavioral:
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Improvement of QoL (Diabetes Quality of Life Youth scale) and family functioning (Family Environment Scale) scores of the experimental group at three months.
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The intervention showed gaps in the knowledge about T1D.
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Franklin et al, Scotland (2006)1616. Franklin VL, Waller A, Pagliarit C, Greene SA. A randomized controlled trial of sweet talk, a text-messaging system to support young people with diabetes. Diabet Med [Internet]. 2006 Dec [cited 2018 Sept 18];23(12):1332-8. Available from: https://doi.org/10.1111/j.1464-5491.2006.01989.x
https://doi.org/10.1111/j.1464-5491.2006...
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To describe the Sweet Talk
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RCT.
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92 young people, 8 to 18 years old, with T1D for at least one year.
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Theme: T1D self-care tasks.
Group 1 (G1): standard care (2-3 doses of premixed insulin). Group 2 (G2): standard care and Sweet Talk Group 3 (G3): basal therapy-bolus and Sweet Talk. (automated system that stores and sends, according to a previous schedule, about 400 text messages by mobile phone, guided by behavioral theories). It includes: a weekly reminder of the successful goals agreed at the clinic; daily messages with tips, information, or reminders to reinforce the goals agreed upon with the health care team concerning insulin application, blood glucose self-monitoring, healthy eating, and exercise. |
Clinical:
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improvement of HbA1c in G3 (p<.001).
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No significant changes were identified in DKA and severe hypoglycemia episodes.
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The BMI increased in G3.
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The use of the health service was greater in G2 and G3 (p=.016).
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Emergency contacts with the health care team were more frequent in G3 than G2 (p=.02).
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Behavioral: improved self-efficacy (Self-Efficacy for Diabetes score) in G2 when compared to G1 (p=.003); increased adherence to the treatment, measured using a visual analog scale (p=.042).
There was no change in knowledge levels (Diabetes Knowledge Score). The social support (Diabetes Social Support Interview) provided by the health care team increased when Sweet Talk was used in G2 and G3 (p<.05). |
Coates et al, Northern Ireland (2013)1717. Coates V, Chaney D, Bunting B, Shorter GM, Shevelin M, McDougall A, Lon A. Evaluation of the effectiveness of a structured diabetes education programme (CHOICE) on clinical outcomes for adolescents with type 1 diabetes: a randomized controlled trial. J Diabetes Metab [Internet]. 2013 [cited 2018 Sept 18];4(6):280. Available from: https://doi.org/10.4172/2155-6156.1000280
https://doi.org/10.4172/2155-6156.100028...
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To evaluate the impact of a diabetes education program for adolescents with T1D (CHOICE): HbA1c, BMI, hypoglycemia and hyperglycemia episodes, and adherence to the diet.
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RCT.
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135 adolescents, 13 to 16 years old. T1D for at least one year.
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Themes: interaction between carbohydrate consumption and insulin requirement; meal times and effects of physical exercise on blood glucose and insulin.
Control-group (CG): standard care every three months, with the professional from the clinic, to solve problems. Experimental group (EG): CHOICE, consisting of four weekly educational sessions, involving one nurse and two dieticians with experience in diabetes at seven hospitals. The duration of the sessions was three hours, plus one dinner to practice carbohydrate counting. These included a curricular guide, plates to standardize the meals, images of individual portions to build custom meals and cards to promote the dialogue. During the breaks between the sessions and at two, four and five months after the intervention, text messages were sent to assess the progress and encourage communication. |
Clinical:
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improved HbA1c in EG after 24 months.
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Greater variation in BMI in CG at 12 months.
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Average of six days of hyperglycemia in the 24-month period, without DKA episodes, in both groups.
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No difference between the groups in the number of hypoglycemic episodes.
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Behavioral: greater adherence to the diet (Diabetes Care Profile) after one, three, and six months in EG. |
Price et al, United Kingdom (2016)1818. Price KJ, Knowles JA, Fox M, Wales JKH, Heller S, Eiser C, et al. Educational and psychological issues effectiveness of the kids in control of food (KICk-OFF) structured education course for 11-16 year olds with Type 1 diabetes. Diabet Med [Internet]. 2016 [cited 2018 Sept 18];33(2):192-203. Available from: https://doi.org/10.1111/dme.12881
https://doi.org/10.1111/dme.12881...
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To analyze the effect of Kids in Control of Food: KICk-OFF on the biomedical and psychological outcomes of young people with T1D.
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RCT.
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370 adolescents, 11 to 16 years old, T1D for at least 1 year.
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Themes: carbohydrate counting and adjustment of insulin doses in daily life; management of hypoglycemia, ketones, and long-term complications.
Control-group (CG): standard care. Experimental group (EG): KICK-OFF (five-day course taught at 17 medical centers). Group education strategy, including written material, support questionnaire and evaluation. Developed by a diabetes nurse and a dietician with expertise in diabetes, and by a member of the local team. The professionals were trained during a five-day course on teaching skills, developed during the pilot study. |
Clinical:
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HbA1c levels without statistically significant differences between the groups over the 24 months (p=.38).
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EG participants with high HbA1c at the beginning of the study showed better results after two years when compared to the CG (p=.03).
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After 24 months, the CG presented worsening of HbA1c levels compared to the EG, in which the decrease continued.
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There was no significant change in the rates of DKA and severe hypoglycemia.
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Behavioral: improved general QoL scores (PedsQL-G) in the experimental group at six- and twelve-months post-intervention (p=.04) and improved scores in physical and psychosocial domains at six months (p=.04).
There was a decrease in disease symptoms (PedsQL-D) at six months (p=.008). After 12 and 24 months, the CG presented high treatment adherence scores (p=.02) and, at six and 12 months, high self-efficacy scores (p=.01 and p=.02). |
Semiz et al, Turkey (2000)1919. Semiz S, Bilgin UO, Bundak R, Bircan I. Summer camps for diabetic children: an experience in Antalya, Turkey. Acta Diabetol [Internet]. 2000 [cited 2018 Sept 18];37(4):197-200. Available from: https://doi.org/10.1007/s005920070005
https://doi.org/10.1007/s005920070005...
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To evaluate the effectiveness of camps for children with diabetes, using objective parameters.
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Quasi-experiment.
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Young people from 8 to 20 years old, T1D for at least 1 year.
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28 participants in Camp 1; 29 participants in Camp 2; 14 participated in both.
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Themes: teaching the insulin injection technique; recognition and management of hyperglycemia and DKA; adjustment of insulin doses based on diet and activities; importance of control and new therapies.
Camps: 10 days long, a health care team comprising pediatric endocrinologists, diabetes nurses and dieticians. Assessment before/after the intervention: participants completed a knowledge questionnaire on diabetes and nutrition before, immediately after and six months after both camps. |
Clinical:
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there was no difference in the mean annual HbA1c level before and after the first camp in all participants (p>.05).
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No difference in the HbA1c level before the first and after both camps (p>.05).
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After the first camp: Weight gain of 1.2 kg in 18 children considered underweight, and weight loss of 0.9 kg in 8 children who were overweight.
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Behavioral: increased knowledge, more noteworthy after the second camp (p<.05). |
Lawson et al, Canada (2000)2020. Lawson ML, Frank MR, Fry MK, Perlman K, Sochett EB, Daneman D. Intensive diabetes management in adolescents with type 1 diabetes: the importance of intensive follow-up. J Pedc Endocrinol Metabol [Internet]. 2000 [cited 2018 Sept 18];13:79-84. Available from: https://doi.org/10.1515/JPEM.2000.13.1.79
https://doi.org/10.1515/JPEM.2000.13.1.7...
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To compare the short-term results of the Intense Diabetes Management Program (IDM).
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Quasi-experiment.
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28 young people, 11 to 20 years old, with nephromegaly detected by ultrasound.
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Themes: action and adjustment of insulin doses; daily glucose monitoring and on days of illness; causes, treatment, and prevention of hypoglycemia episodes; food plan and carbohydrate counting.
Group 1: customized education on IDM + intense clinical follow-up for three months; six-eight hours of educational intervention, distributed in three-four sessions conducted at a diabetes center by a diabetes nurse, a dietician and a researcher. Weekly telephone contact initiated by the researcher. Group 2: IDM as part of the diabetes care routine, educational sessions in groups of up to 20 people, conducted by a diabetes nurse specialist, a dietician, and a diabetologist. Encouraged telephone contact (patient's initiative). IDM: multiple-dose regimen of regular (IR) or ultrafast insulin before meals and NPH before bedtime. IR doses were adjusted according to the pre-prandial glucose level, amount of carbohydrates ingested and planned physical exercise after the meal. All participants were instructed to monitor blood glucose levels four times a day. |
Clinical outcomes only:
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Group 1: mean decrease in HbA1c of 2.5% in the first three months (p<.0001). Episodes of severe hypoglycemia occurred.
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Group 2: mean HbA1c decreased by 0.9% in the first three months (p=.05). There were no episodes of severe hypoglycemia.
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Considerable increase in HbA1c in both groups one year after the intervention.
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There was no difference between the mean HbA1c in both groups at 15 months after the beginning of IDM (p=.8).
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No episodes of DKA were observed in both groups.
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Von Sengbusch et al, Germany (2005)2121. Von Sengbusch S, Muller-Godeffroy E, Hager S, Reintjes R, Hiort O, Wagner V. Mobile diabetes education and care: intervention for children and young people with type 1 diabetes in rural areas of northern Germany. Diabet Med [Internet]. 2006 [cited 2018 Sept 18];23(2):122-7. Available from: https://doi.org/10.1111/j.1464-5491.2005.01754.x
https://doi.org/10.1111/j.1464-5491.2005...
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To evaluate the effectiveness of standardized and structured diabetes education, developed by a remote team.
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Quasi-experiment.
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107 children with mean age 11.1 ± 2.5 years old and T1D for at least six months.
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Theme: function of insulin and parent empowerment to adjust doses according to daily events and challenges.
Five-day course (Monday to Friday), which three researchers conducted at eight state hospitals in cooperation with the local health team. Group education, including four to six children of the same age group. Individual or group education for parents, one to two times a week. Data collected before (t0), at six weeks (t1), and at six months (t2) after the intervention. |
Clinical:
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children with HbA1c > 8% before the intervention significantly improved MC between t0 and t1, and t0 and t2, regardless of changes in insulin therapy and the number of glucose monitoring checks per day (p<.01).
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Children with HbA1c <6.8% increased the level between t0 and t1(p>.05), and between t0 and t2 (p<.05).
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There was no significant difference in HbA1c at the three measurement times (P>.05), nor in the number of severe hypoglycemia episodes (p>.05), but there was a significant reduction in the number of hospital admissions (p<.05).
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Behavioral: diabetes knowledge increased at t1 and t2 compared to t0 (p<.05). Adolescents who lived with a single parent obtained a higher knowledge score when compared to those who lived with both parents (p<.05).
Improved QoL (German KINDL R quality-of-life questionnaire) at t1 (p<.05) and t2 (p<.01). Satisfaction with the intervention (German CSQ-8 Client Satisfaction Questionnaire) was high: 57.4% of children rated it as ‘very good’ at t1. |
Qayyum et al, Pakistan (2010)2222. Qayyum AA, Lone SW, Ibrahim MN, Atta I, Raza J. Effects of diabetes self-management education on glycaemic control in children with insulin-dependent diabetes mellitus. J Coll Physicians Surg Pak [Internet]. 2010 Dec [cited 2018 Sept 18];20(12):802-5. Available from: https://doi.org/12.2010/JCPSP.802805.
https://doi.org/12.2010/JCPSP.802805....
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To evaluate the effectiveness of Diabetes Self-Management Education (DSME) in glycemic control of Pakistani children with T1D.
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Quasi-experiment.
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50 children, mean age 10 years, and age of diagnosis 8.15±3.02 years.
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Theme: specific module on insulin therapy that addressed types of insulin, preparation of the injection, application sites and forms, where/how/for how long insulin can be stored.
DSME: educational program of a pediatric diabetes clinic, organized in four modules consisting of 1.5-hour lectures, offered for groups of 10 children and their parents/caregivers. At the end, the participants received a glucose meter with reagent strips, a blood glucose diary, educational leaflets, nutritional diary, and an identification card and bracelet, as well as a doll with highlighted application sites. Monthly follow-up with a pediatric endocrinologist, a pediatrician, a dietician, a diabetes nurse after the intervention, with telephone reminders one week before the appointment. |
Clinical outcomes only:
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Mukama et al, Tanzania (2013)2323. Mukama LJ, Moran A, Nyindo M, Philemon R, Msuya L. Improved glycemic control and acute complications among children with type 1 diabetes mellitus in Moshi, Tanzania. Ped Diabet [Internet]. 2013 [cited 2018 Sept 18];14:211-216. Available from: https://doi.org/10.1111/pedi.12005
https://doi.org/10.1111/pedi.12005...
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To analyze the impact of a diabetes education and management program: glycemic control and chronic complications of children and adolescents in Tanzania.
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Quasi-experiment.
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81 participants, 0 to 17 years old, with T1D for at least six months.
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Themes: prevention and treatment of hypoglycemia; prevention of hypoglycemia due to incorrect insulin application; caution with excessive physical activity and skipping meals; calculations of insulin dosages and storage methods; recognition and prevention of DKA. |
Clinical outcomes only:
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there was no improvement in HbA1c at six months after the intervention (p=.1).
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There was no statistically significant association between the results of HbA1c and gender (p=.06), nor with medical returns (p=.89) or insulin dosage (p=.17).
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The number of hypoglycemia episodes dropped by 2/3 at six months (p=.65).
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DKA episodes were associated with the lack of insulin doses (p<.05) and blood glucose monitoring at home.
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