Table 1 Characteristics of included individually randomized and cluster-randomized clinical trials
Author (year) Clinicaltrials.gov ID | Design | Setting, country | Total (n) | Intervention | Control group | Participants | Type of diabetes | Mean age | Mean duration of diabetes (years) | Deliverer | Outcomes | Follow-up time points (months) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Brorson et al. (2019) [30] | A cluster-randomized controlled trial | Outpatient setting, Sweden | 71 | Guided self-determination (group based) | Standardized pump start education, follow-up after 1 week, follow-up after 4–6 weeks and 4 months after start | Adolescents (12–18 years) | Type 1 | 15.1 years (12–17.99) | NRa | “Guided self-determination youth group leaders (educational background not described) | Primary outcome: Hba1c Secondary outcomes: DISABKIDS, check your health, the Diabetes Family Conflict scale (DFCS), the Swedish Diabetes Empowerment Scale (Swe-DES 23), usage of continuous glucose monitoring system. Multiple daily injections | 6 and 12 months |
Husted et al. (2014) [31] | A randomized clinical trial | Outpatient setting, Denmark | 71 | Guided self-determination (revised for adolescents) | Eight sessions scheduled equal to the intervention group across an 8- to 12-month period, with a duration of 30 to 45 min. They received HbA1c measurement, advice on glycemic control, and insulin administration. Parents participated | Adolescents (13–18 years) HbA1c > 64 mmol/mol | Type 1 | 15 years | 5.7 years | Two pediatric physicians, five pediatric diabetes nurses, and two dieticians (HCPs) provided the GSD-Y intervention | Perceived competence for diabetes management (PCD), Health Care Climate Questionnaire (HCCQ) assessing the degree to which patients believed their HCPs to be autonomy supportive versus Treatment Self-Regulation Questionnaire (TSRQ) assessing the motivation for diabetes management and the degree to which behaviors tended to be self-determined. Problem Areas in Diabetes (PAID) assessing diabetes-related distress including a wide range of feelings related to living with diabetes and the Perception of Parents Scale (POPS) | Intervention group 215 ± 59 days versus control group 246 ± 83 days |
Mohn et al. (2017) [32] ClinicalTrials. gov NCT 01317459 | A randomized clinical trial | Outpatient setting, Norway | 178 (62% women) | Guided self-determination (group based) | Usual care | Adults (> 18 years old), HbA1c > 64 mmol/mol | Type 1 | 18–55 years, mean age 36.7 ± 10.7 | 19 years, range (1–46) | Diabetes specialist nurses trained in the guided self-determination method | HbA1c Self-monitored blood glucose (SMBG), PAID; DDS, PCDS, Rosenberg Self-Esteem Scale (RSES), WHO-5, HCCQ, TSRQ, treatment Relative Autonomy Index (RAI) | 9 months |
Zoffmann et al. (2006) [15] | A randomized clinical trial | Outpatient setting, Denmark | 50 | Guided self-determination (group based) | Delayed group training | Adults (> 18 years old), HbA1c > 64 mmol/mol | Type 1 | 36.8 ± 1.7 (exp.) 35.7 ± 2.1 (cont.) | Age at onset of diabetes 18.2 ± 2 (exp.) 13 ± 2.2 (cont.) | Nurses trained in the guided self-determination method | Health Care Climate Questionnaire (HCCQ) Treatment Self-Regulation Questionnaire (TSRQ) Perceived Competence in Diabetes Scale (PCD) Problem Areas in Diabetes (PAID) | 12 months |
Zoffmann et al. (2015) [16, 33] Trial registration: ISRCTN70566290 | A randomized clinical trial | Outpatient setting, Denmark | 200, balanced 2:1 | Guided self-determination (group based or individual) | 18-month delayed GSD intervention During the control period, participants received care as usual and met for sessions with nurse, doctor, or dieticians every 3–4 months | Adults (18 to 35 years old), HbA1c ≥ 64 mmol/mol | Type 1 | 25.7 | 13.7 | Seven diabetes nurse specialists with 7–25 years of experience within the field of diabetes. They were GSD certified passing a test after 40 h of systematized training in the theoretical background and practical use of GSD, and all of them were supervised by V. Z. | Primary outcome: HbA1c Secondary outcomes: PAID, WHO-5, Rosenberg SES, Perceived Competence in Diabetes (PCD, Treatment Self-regulation Questionnaire (TSRQ), SMBG, Autonomy Index | HbA1c: 3, 6, 9, 12, 15, 18 months Secondary outcomes 9 and 18 months |
Juul et al. (2014) [34] ClinicalTrials.gov identifier: NCT01187069 | A cluster-randomized trial | General practice, Denmark | 4035 (56.5% men) | Self-determination theory (individual) | Usual practice at their general practitioner | NR | Type 1 (15% and type 2 85%) | 60.4 ± 8.6 years | 8 years | A total of 34 nurses from 19 of 20 intervention practices had received the core intervention. 22 nurses from the 13 practices had completed the full course | Primary outcomes: HbA1c, total cholesterol, PAID | 18 months (average) |
Mathiesen (2019) [35] | A randomized clinical feasibility trial | Outpatient clinic setting, Denmark | 20 | Guided self-determination (individual) | Usual care | Adults (> 18 years old), HbA1c > 53 mmol/mol | Type 2 diabetes | 58 years (mean) | NR | The guided self-determination intervention was provided by the PhD student certified in the method | Primary outcomes: HbA1c, diabetes distress, depressive symptoms, physical activity, hip/waist ratio, eating habits | 4-month follow-up |
Nansel et al. (2015) [36] ClinicalTrials.gov identifier: NCT00999375 | A randomized clinical trial | Outpatient clinic setting, USA | 136 (48.5% male) | Self-determination theory (Individual) | Received an equal amount of session and frequency of contacts with research staff and an equal frequency of 3-day masked CGM. Participants in the control group received no additional dietary advice beyond that provided as part of standard type 1 diabetes care. Scales, measuring cops, and spoons were provided to both groups | Adolescents 8–16.9 years old), HbA1c ≥ 6.5%, and ≤ 10% | Type 1 | NR | 6.0 years | Research assistants trained in pediatric T1 diabetes, intervention procedures, and motivational interviewing. Study investigators provided feedback to audiotaped role-play practice sessions prior to intervention delivery and on a random sample of audiotaped intervention sessions | Primary outcomes: diet quality, measured by the Healthy Eating Index 2005 (HEI2005), the whole plant food density (WPFD), measure and Hba1c | 15 and 18 months |
Vanroy et al. (2017) [23] Clinical Trials.gov NCT 02064335 | A randomized controlled pilot trial | Belgium | 48 (27 men and 21 women) | Self-determination theory (individual) | Similar intervention 6 months delayed. The participants in the control group were told that during the waiting period, their health measurements were analyzed |  ≥ 18 years old | Type 2 diabetes | Experimental group: 65 ± 8 Control group: 59 ± 8 | NR | An intake and an outtake session with a professional PA coach, who held the degree of Master in Physical Education and Movement Sciences and who was familiarized with SDT and motivational interviewing | Hba1c and measurement of physical activity (armband SenseWear). A minimum of 3 weekdays and 1 weekend day was considered a valid measurement week | 1–5 months and 6 months |
Glasgow et al. (2005) [24] | A randomized clinical trial | Outpatient clinic setting, USA | 886 | Self-determination theory (individual) | Participants completed a touch screen computer assessment procedure involving the Provider Recognition Program measures as well as a general health risk appraisal items (e.g., use of seatbelts, cancer screening, etc.). They had the same number of visits as intervention patients and received a printout but one that focused on general health tasks and risk reduction that did not address the DPP |  ≥ 25 years old | Type 2 diabetes | Intervention 62 ± 1.4 Control 64 ± 1.3 | NR | NR | Primary outcomes: self-management goalsetting medical nutrition therapy, dilated eye examination, foot examination Secondary outcomes: PAID 2, PHQ-9 depression scale, lipids and HbA1c, blood pressure, microalbuminuria | 12 months |
Yun et al. (2020) [37] ChiCTR1900024354 | A cluster-randomized controlled trial | General practitioner, China | 364 | Self-determination theory (group based or individual) | 2 control group interventions  1) Usual care group offering regular public health management services  2) Social support group (SSG) providing 3-month social support intervention based on problem-solving principles |  ≥ 18 years old | Type 2 diabetes | 65.14 ± 7.23 years old | NR | Community doctors | Primary outcome: HbA1c | 3 and 6 months |